| ID | Type | Description | Link |
|---|---|---|---|
| N01HC95178 | U.S. NIH Grant/Contract | View source | |
| N01HC95179 | U.S. NIH Grant/Contract | View source | |
| N01HC95180 | U.S. NIH Grant/Contract | View source | |
| N01HC95181 | U.S. NIH Grant/Contract | View source | |
| N01HC95182 | U.S. NIH Grant/Contract | View source | |
| N01HC95183 | U.S. NIH Grant/Contract | View source | |
| N01HC95184 | U.S. NIH Grant/Contract | View source | |
| IAA#Y1HC9035 | Other Grant/Funding Number | U.S. Centers for Disease Control | |
| IAA#Y1HC1010 | Other Grant/Funding Number | U.S. Centers for Disease Control |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institute on Aging (NIA) | NIH |
| National Eye Institute (NEI) | NIH |
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The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
BACKGROUND:
Currently, about 17 million Americans have been diagnosed with diabetes and more than 90 percent of them have type 2 diabetes. The number of people with this form of diabetes, formerly known as adult onset or non-insulin dependent diabetes, is growing rapidly. By 2050, the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million, of whom 27 million will have the type 2 form. Cardiovascular disease (CVD) is the leading cause of death in people with type 2 diabetes; these individuals die of CVD at rates two to four times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes.
Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes. Women with a history of diabetes during pregnancy, adults with impaired glucose tolerance, people with a sedentary lifestyle, and members of a minority race/ethnicity are also at a greater risk for developing type 2 diabetes. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes.
DESIGN NARRATIVE:
The three strategies tested in ACCORD included the following: (1) Blood sugar - ACCORD was designed to determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk. The study estimated effects on CVD of that level compared with a level that is usually targeted. (2) Blood pressure - many people with type 2 diabetes have high blood pressure. The blood pressure part of the trial was designed to determine the effects of lowering blood pressure in the context of good blood sugar control, that is to determine whether lowering blood pressure to normal (systolic pressure less than 120 mm Hg) will better reduce CVD risk, as compared to a usually-targeted level in current clinical practice (i.e., below the definition of hypertension; systolic pressure less than 140 mm Hg). (3) Blood Fats - Many people with diabetes have high levels of LDL ("bad") cholesterol and triglycerides, as well as low levels of HDL ("good") cholesterol. ACCORD participants who are selected for this part of the trial were assigned to an intervention to improve blood fat levels. This part of the study looked at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol, all in the context of good blood sugar control. A drug from a class of drugs called "fibrates" was used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" was used to lower LDL cholesterol.
All ACCORD participants received blood sugar treatment from the study. Based on the second trial (Blood Pressure or Lipid) they were assigned to, participants also received their high blood pressure or cholesterol care from the study. Study participants received all medication and treatments related to the study free of charge. Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care.
In summary, the ACCORD Study was a double 2x2 factorial design with factors consisting of: intensive versus standard glycemic control, intensive versus standard blood pressure control, and blinded fenofibrate or placebo in combination with simvastatin to maintain desirable LDL-C levels. All 10,251 participants were randomized to the glycemic interventions; a subgroup of 4,733 participants who met the blood pressure entry criteria were randomized to the blood pressure interventions in one 2x2 trial; and a distinct subgroup of 5,518 participants who met the lipid entry criteria were randomized to the lipid interventions in the second 2x2 trial. All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites).
On February 6, 2008, the National Heart, Lung and Blood Institute (NHLBI) announced that participants in the intensive glycemia treatment would be transitioned to the ACCORD standard glycemic treatment approach due to higher mortality in the intensive treatment group terminating the experimental arm of the Glycemia Trial early. The Blood Pressure and Lipid trials continued as designed to their planned termination in 2009.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycemia Trial: intensive control | Experimental | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. |
|
| Glycemia Trial: standard control | Active Comparator | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 - 7.9%. |
|
| BP Trial: intensive control | Experimental | Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. |
|
| BP Trial: standard control | Active Comparator | Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. |
|
| Lipid Trial: fenofibrate | Experimental | Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-hyperglycemic Agents | Drug | Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%). |
| Measure | Description | Time Frame |
|---|---|---|
| First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion. | 4.9 years |
| First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. | 4.7 years |
| First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. | 4.7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death From Any Cause in the Glycemia Trial. | Time to death from any cause. Secondary measure for Glycemia Trial. A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Simons-Morton, MD, PhD | National Heart, Lung, and Blood Institute (NHLBI) | Study Director |
| William Friedewald, MD | Columbia University | Study Chair |
| Robert Byington, PhD | Wake Forest University, Winston-Salem, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Medical Research Foundation | Minneapolis | Minnesota | 55404 | United States | ||
| Columbia University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17599425 | Background | Cushman WC, Grimm RH Jr, Cutler JA, Evans GW, Capes S, Corson MA, Sadler LS, Alderman MH, Peterson K, Bertoni A, Basile JN; ACCORD Study Group. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):44i-55i. doi: 10.1016/j.amjcard.2007.03.005. Epub 2007 Apr 16. | |
| 17599421 | Background | Williamson JD, Miller ME, Bryan RN, Lazar RM, Coker LH, Johnson J, Cukierman T, Horowitz KR, Murray A, Launer LJ; ACCORD Study Group. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. doi: 10.1016/j.amjcard.2007.03.029. Epub 2007 Apr 12. |
| Label | URL |
|---|---|
| Click here for the ACCORD trial web site | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| ACCORD | Individual Participant Data Set | View IPD |
Eligible participants provided evidence of ability to routinely monitor capillary blood sugars from written records or electronic downloads from a self-monitoring blood glucose device (SMBG), or (in cases where such records could not be provided) underwent a 2 to 4-week pre-randomization run-in period to evaluate compliance with SMBG monitoring.
All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites). Recruitment occurred in two phases, from January to June 2001 and from February 2003 to October 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycemia Trial: Intensive Control/BP Trial: Intensive Control | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Centers for Disease Control and Prevention |
| FED |
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|
| Lipid Trial: placebo | Placebo Comparator | Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin. |
|
|
| Anti-hypertensive Agents | Drug | Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg). |
|
|
| Blinded fenofibrate or placebo plus simvastatin | Drug | Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
|
|
| 4.9 years |
| Stroke in the Blood Pressure Trial. | Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. | 4.7 years |
| First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. | 4.7 years |
| New York |
| New York |
| 10027 |
| United States |
| Wake Forest University | Winston-Salem | North Carolina | 27106 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Veterans Affairs | Memphis | Tennessee | 38104 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| McMaster University | Hamilton | Ontario | Canada |
| 17599429 | Background | Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, Narayan KM, Nwachuku C, O'Connor PJ, Zhang P; ACCORD Study Group. Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007 Jun 18;99(12A):90i-102i. doi: 10.1016/j.amjcard.2007.03.027. Epub 2007 Apr 13. |
| 17599428 | Background | Bonds DE, Kurashige EM, Bergenstal R, Brillon D, Domanski M, Felicetta JV, Fonseca VA, Hall K, Hramiak I, Miller ME, Osei K, Simons-Morton DG; ACCORD Study Group. Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):80i-89i. doi: 10.1016/j.amjcard.2007.03.026. Epub 2007 Apr 17. |
| 17599427 | Background | Kingry C, Bastien A, Booth G, Geraci TS, Kirpach BR, Lovato LC, Margolis KL, Rosenberg Y, Sperl-Hillen JM, Vargo L, Williamson JD, Probstfield JL; ACCORD Study Group. Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):68i-79i. doi: 10.1016/j.amjcard.2007.03.025. Epub 2007 Apr 12. |
| 17599426 | Background | Ginsberg HN, Bonds DE, Lovato LC, Crouse JR, Elam MB, Linz PE, O'connor PJ, Leiter LA, Weiss D, Lipkin E, Fleg JL; ACCORD Study Group. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):56i-67i. doi: 10.1016/j.amjcard.2007.03.024. Epub 2007 Apr 12. |
| 17599424 | Background | Goff DC Jr, Gerstein HC, Ginsberg HN, Cushman WC, Margolis KL, Byington RP, Buse JB, Genuth S, Probstfield JL, Simons-Morton DG; ACCORD Study Group. Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):4i-20i. doi: 10.1016/j.amjcard.2007.03.002. Epub 2007 Apr 12. |
| 17599423 | Background | Gerstein HC, Riddle MC, Kendall DM, Cohen RM, Goland R, Feinglos MN, Kirk JK, Hamilton BP, Ismail-Beigi F, Feeney P; ACCORD Study Group. Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):34i-43i. doi: 10.1016/j.amjcard.2007.03.004. Epub 2007 Apr 19. |
| 17599422 | Background | ACCORD Study Group; Buse JB, Bigger JT, Byington RP, Cooper LS, Cushman WC, Friedewald WT, Genuth S, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH Jr, Margolis KL, Probstfield JL, Simons-Morton DG, Sullivan MD. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007 Jun 18;99(12A):21i-33i. doi: 10.1016/j.amjcard.2007.03.003. Epub 2007 Apr 16. |
| 17599420 | Background | Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13. |
| 18539917 | Result | Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6. |
| 42312207 | Derived | Chlebek C, Bussberg V, Narain NR, Kiebish MA, Tseng YH, Rosen CJ, Lynes MD. Baseline serum metabolites predict fractures in individuals who were Black and had type 2 diabetes. Front Endocrinol (Lausanne). 2026 Jun 2;17:1777636. doi: 10.3389/fendo.2026.1777636. eCollection 2026. |
| 41903707 | Derived | Liu Y, Lyu Y, Liu Y, Zhang J, Song Z, Chen K, Jiang Z, Yan H, Chen T, Li C. Individual participant-level analysis of four randomized clinical trials examined therapeutic effects of blood pressure lowering on hierarchical kidney outcome using win statistics. Kidney Int. 2026 Jul;110(1):178-189. doi: 10.1016/j.kint.2026.02.032. Epub 2026 Mar 26. |
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| 41216699 | Derived | Lavallee SK, Carew AS, Warren RA, Sapp JL, Levy AP, Andreou P, Herman CR, Rimm EB, Cahill LE. Haptoglobin Phenotype and Cardiovascular Risk: The ACCORD Blood Pressure RCT. Hypertension. 2026 Jan;83(1):189-198. doi: 10.1161/HYPERTENSIONAHA.125.25021. Epub 2025 Nov 11. |
| 41127917 | Derived | Sano Y, Jin R, Yoshioka H, Nakazato Y, Sato H, Hisaka A. Development of a Novel Machine Learning Method for Estimation of Life-Long Chronic Disease Progression and Its Application to Type 2 Diabetes. Clin Transl Sci. 2025 Oct;18(10):e70351. doi: 10.1111/cts.70351. |
| 40845203 | Derived | Wang J, Lv W, Wang Z, Li S, Wang Z, Zhou L, Wang Y, Ren L, Jiang C, He L, Xia S, Kong X, Zuo S, Kong Y, Guo X, Liu X, Li S, Tang R, Long D, Sang C, Zhou N, Du X, Dong J, Ma C. Orthostatic Systolic Blood Pressure Elevation and Incident Atrial Fibrillation: Insights From the SPRINT Trial. J Clin Hypertens (Greenwich). 2025 Aug;27(8):e70122. doi: 10.1111/jch.70122. |
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| 26476086 | Derived | Chen LY, Bigger JT, Hickey KT, Chen H, Lopez-Jimenez C, Banerji MA, Evans G, Fleg JL, Papademetriou V, Thomas A, Woo V, Seaquist ER, Soliman EZ. Effect of Intensive Blood Pressure Lowering on Incident Atrial Fibrillation and P-Wave Indices in the ACCORD Blood Pressure Trial. Am J Hypertens. 2016 Nov 1;29(11):1276-1282. doi: 10.1093/ajh/hpv172. |
| 26464212 | Derived | Siraj ES, Rubin DJ, Riddle MC, Miller ME, Hsu FC, Ismail-Beigi F, Chen SH, Ambrosius WT, Thomas A, Bestermann W, Buse JB, Genuth S, Joyce C, Kovacs CS, O'Connor PJ, Sigal RJ, Solomon S; ACCORD Investigators. Insulin Dose and Cardiovascular Mortality in the ACCORD Trial. Diabetes Care. 2015 Nov;38(11):2000-8. doi: 10.2337/dc15-0598. Epub 2015 Oct 13. |
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| 26261902 | Derived | Chow LS, Chen H, Miller ME, Marcovina SM, Seaquist ER. Biomarkers associated with severe hypoglycaemia and death in ACCORD. Diabet Med. 2016 Aug;33(8):1076-83. doi: 10.1111/dme.12883. Epub 2015 Sep 6. |
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| 25666468 | Derived | Espeland MA, Probstfield J, Hire D, Redmon JB, Evans GW, Coday M, Lewis CE, Johnson KC, Wilmoth S, Bahnson J, Dulin MF, Green JB, Knowler WC, Kitabchi A, Murillo AL, Osei K, Rehman SU, Cushman WC; Look AHEAD Research Group; ACCORD Study Group. Systolic Blood Pressure Control Among Individuals With Type 2 Diabetes: A Comparative Effectiveness Analysis of Three Interventions. Am J Hypertens. 2015 Aug;28(8):995-1009. doi: 10.1093/ajh/hpu292. Epub 2015 Feb 9. |
| 25652389 | Derived | Chow LS, Chen H, Miller ME, Marcovina SM, Seaquist ER. Biomarkers related to severe hypoglycaemia and lack of good glycaemic control in ACCORD. Diabetologia. 2015 Jun;58(6):1160-6. doi: 10.1007/s00125-015-3512-0. Epub 2015 Feb 5. |
| 25267796 | Derived | Zhang Z, Lovato J, Battapady H, Davatzikos C, Gerstein HC, Ismail-Beigi F, Launer LJ, Murray A, Punthakee Z, Tirado AA, Williamson J, Bryan RN, Miller ME. Effect of hypoglycemia on brain structure in people with type 2 diabetes: epidemiological analysis of the ACCORD-MIND MRI trial. Diabetes Care. 2014 Dec;37(12):3279-85. doi: 10.2337/dc14-0973. Epub 2014 Sep 29. |
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| 25193529 | Derived | Hugenschmidt CE, Lovato JF, Ambrosius WT, Bryan RN, Gerstein HC, Horowitz KR, Launer LJ, Lazar RM, Murray AM, Chew EY, Danis RP, Williamson JD, Miller ME, Ding J. The cross-sectional and longitudinal associations of diabetic retinopathy with cognitive function and brain MRI findings: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care. 2014 Dec;37(12):3244-52. doi: 10.2337/dc14-0502. Epub 2014 Sep 5. |
| 25172198 | Derived | Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT; Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014 Dec;121(12):2443-51. doi: 10.1016/j.ophtha.2014.07.019. Epub 2014 Aug 29. |
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| 24493100 | Derived | Williamson JD, Launer LJ, Bryan RN, Coker LH, Lazar RM, Gerstein HC, Murray AM, Sullivan MD, Horowitz KR, Ding J, Marcovina S, Lovato L, Lovato J, Margolis KL, Davatzikos C, Barzilay J, Ginsberg HN, Linz PE, Miller ME; Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Investigators. Cognitive function and brain structure in persons with type 2 diabetes mellitus after intensive lowering of blood pressure and lipid levels: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):324-33. doi: 10.1001/jamainternmed.2013.13656. |
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| 23990163 | Derived | Barzilay JI, Lovato JF, Murray AM, Williamson J, Ismail-Beigi F, Karl D, Papademetriou V, Launer LJ. Albuminuria and cognitive decline in people with diabetes and normal renal function. Clin J Am Soc Nephrol. 2013 Nov;8(11):1907-14. doi: 10.2215/CJN.11321112. Epub 2013 Aug 29. |
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| 23238658 | Derived | Gerstein HC, Ambrosius WT, Danis R, Ismail-Beigi F, Cushman W, Calles J, Banerji M, Schubart U, Chew EY; ACCORD Study Group. Diabetic retinopathy, its progression, and incident cardiovascular events in the ACCORD trial. Diabetes Care. 2013 May;36(5):1266-71. doi: 10.2337/dc12-1311. Epub 2012 Dec 13. |
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| 22619083 | Derived | Sullivan MD, O'Connor P, Feeney P, Hire D, Simmons DL, Raisch DW, Fine LJ, Narayan KM, Ali MK, Katon WJ. Depression predicts all-cause mortality: epidemiological evaluation from the ACCORD HRQL substudy. Diabetes Care. 2012 Aug;35(8):1708-15. doi: 10.2337/dc11-1791. Epub 2012 May 22. |
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| 21366473 | Derived | ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524. |
| 20594588 | Derived | Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles J, Cohen RM, Cuddihy R, Cushman WC, Genuth S, Grimm RH Jr, Hamilton BP, Hoogwerf B, Karl D, Katz L, Krikorian A, O'Connor P, Pop-Busui R, Schubart U, Simmons D, Taylor H, Thomas A, Weiss D, Hramiak I; ACCORD trial group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet. 2010 Aug 7;376(9739):419-30. doi: 10.1016/S0140-6736(10)60576-4. Epub 2010 Jun 30. |
| 20587587 | Derived | ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29. |
| 20571135 | Derived | Strylewicz G, Doctor J. Evaluation of an automated method to assist with error detection in the ACCORD central laboratory. Clin Trials. 2010 Aug;7(4):380-9. doi: 10.1177/1740774510372779. Epub 2010 Jun 22. |
| 20427682 | Derived | Riddle MC, Ambrosius WT, Brillon DJ, Buse JB, Byington RP, Cohen RM, Goff DC Jr, Malozowski S, Margolis KL, Probstfield JL, Schnall A, Seaquist ER; Action to Control Cardiovascular Risk in Diabetes Investigators. Epidemiologic relationships between A1C and all-cause mortality during a median 3.4-year follow-up of glycemic treatment in the ACCORD trial. Diabetes Care. 2010 May;33(5):983-90. doi: 10.2337/dc09-1278. |
| 20228404 | Derived | ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14. |
| 20228401 | Derived | ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14. |
| 20215456 | Derived | Pop-Busui R, Evans GW, Gerstein HC, Fonseca V, Fleg JL, Hoogwerf BJ, Genuth S, Grimm RH, Corson MA, Prineas R; Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of cardiac autonomic dysfunction on mortality risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care. 2010 Jul;33(7):1578-84. doi: 10.2337/dc10-0125. Epub 2010 Mar 9. |
| 20061360 | Derived | Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J, Childress RD, Craven TE, Cuddihy RM, Dailey G, Feinglos MN, Ismail-Beigi F, Largay JF, O'Connor PJ, Paul T, Savage PJ, Schubart UK, Sood A, Genuth S; ACCORD Investigators. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b5444. doi: 10.1136/bmj.b5444. |
| 20061358 | Derived | Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, Dudl RJ, Ismail-Beigi F, Kimel AR, Hoogwerf B, Horowitz KR, Savage PJ, Seaquist ER, Simmons DL, Sivitz WI, Speril-Hillen JM, Sweeney ME. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b4909. doi: 10.1136/bmj.b4909. |
| 19898642 | Derived | Meier M, Hummel M. Cardiovascular disease and intensive glucose control in type 2 diabetes mellitus: moving practice toward evidence-based strategies. Vasc Health Risk Manag. 2009;5:859-71. doi: 10.2147/vhrm.s4808. Epub 2009 Nov 2. |
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement. |
| Study Protocol | View IPD |
| Study Forms | View IPD |
| Manual of Procedures | View IPD |
| FG001 | Glycemia Trial: Intensive Control/BP Trial: Standard Control | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. |
| FG002 | Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
| FG003 | Glycemia Trial: Intensive Control/Lipid Trial: Placebo | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
| FG004 | Glycemia Trial: Standard Control/BP Trial: Intensive Control | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. |
| FG005 | Glycemia Trial: Standard Control/BP Trial: Standard Control | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg). |
| FG006 | Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
| FG007 | Glycemia Trial: Standard Control/Lipid Trial: Placebo | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glycemia Trial: Intensive Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. |
| BG001 | Glycemia Trial: Standard Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Previous cardiovascular disease (CVD) event | Number | participants |
| ||||||||||||||||
| Glycated hemoglobin | Mean | Standard Deviation | percent |
| |||||||||||||||
| Blood pressure | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Cholesterol | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Triglycerides | Median | Inter-Quartile Range | mg/dL |
| |||||||||||||||
| Diabetes duration | Median | Inter-Quartile Range | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion. | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | Posted | Number | participants | 4.9 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death From Any Cause in the Glycemia Trial. | Time to death from any cause. Secondary measure for Glycemia Trial. A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid). | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death. | Posted | Number | participants | 4.9 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | Posted | Number | participants | 4.7 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stroke in the Blood Pressure Trial. | Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke. | Posted | Number | participants | 4.7 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | Posted | Number | participants | 4.7 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event. | Posted | Number | participants | 4.7 years |
|
|
Includes Serious Adverse Events (SAEs) reported after randomization and throughout the planned observation period, mean follow-up was 4.9 years. Data on other (non-serious) adverse events were not collected.
SAEs were defined as any adverse experience that was significantly life threatening and/or resulted in death, permanent disability, hospitalization or prolongation of hospitalization, myositis/myopathy, or hepatitis and were considered by the investigators to be possibly, probably, or definitely related to study treatments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glycemia Trial: Intensive Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | 137 | 5,128 | 0 | 0 | ||
| EG001 | Glycemia Trial: Standard Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | 107 | 5,123 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia, tachycardia, atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Angina/chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Dizziness, hypotension, syncope | Vascular disorders | Non-systematic Assessment |
| ||
| Edema | Vascular disorders | Systematic Assessment |
| ||
| Cerebrovacular accident | Vascular disorders | Systematic Assessment |
| ||
| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hepatitis/liver failure | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Elevated creatinine, hyponatremia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Endocrine disorders | Non-systematic Assessment |
| ||
| Ketoacidosis | Endocrine disorders | Non-systematic Assessment |
| ||
| Hypoglycemia (fatal) | Endocrine disorders | Non-systematic Assessment |
| ||
| Acute or chronic renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Angioedema | Immune system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Immune system disorders | Non-systematic Assessment |
| ||
| Blood dyscrasia | Immune system disorders | Non-systematic Assessment |
| ||
| Felodipine toxicity | Immune system disorders | Non-systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Rhabdomyolisis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fractures | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Macular edema | Eye disorders | Non-systematic Assessment |
| ||
| Blurred vision | Eye disorders | Non-systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Motor vehicle accident (fatal) | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hyperkalemia | General disorders | Non-systematic Assessment |
| ||
| Hyponatremia | General disorders | Non-systematic Assessment |
| ||
| Severe fluid retention | General disorders | Non-systematic Assessment |
| ||
| Dehydration | General disorders | Non-systematic Assessment |
| ||
| Vertigo | General disorders | Non-systematic Assessment |
| ||
| Anemia | General disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | General disorders | Non-systematic Assessment |
| ||
| Hyperosmolar nonketotic coma | General disorders | Non-systematic Assessment |
| ||
| Toxic metabolic enecphalopathy | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Craven / Senior Biostatistician | Wake Forest School of Medicine | 336-716-6109 | tcraven@wakehealth.edu |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| D006937 | Hypercholesterolemia |
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C057619 | glimepiride |
| D008687 | Metformin |
| C072379 | repaglinide |
| D000077154 | Rosiglitazone |
| D000077205 | Pioglitazone |
| D007328 | Insulin |
| D000068880 | Isophane Insulin, Human |
| D061267 | Insulin Aspart |
| D000069057 | Insulin Detemir |
| D000069036 | Insulin Glargine |
| D020909 | Acarbose |
| D000959 | Antihypertensive Agents |
| C044946 | benazepril |
| D017706 | Lisinopril |
| D017257 | Ramipril |
| D002752 | Chlorthalidone |
| D008790 | Metoprolol |
| D004110 | Diltiazem |
| D015736 | Felodipine |
| C041226 | Terazosin |
| C081643 | candesartan |
| C077793 | candesartan cilexetil |
| D000068756 | Valsartan |
| D005665 | Furosemide |
| D012110 | Reserpine |
| D006830 | Hydralazine |
| D000077261 | Carvedilol |
| D014223 | Triamterene |
| D006852 | Hydrochlorothiazide |
| C020743 | hydrochlorothiazide-triamterene |
| C091365 | hydrochlorothiazide, lisinopril drug combination |
| D017311 | Amlodipine |
| D019821 | Simvastatin |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007336 | Insulin, Isophane |
| D049528 | Insulin, Long-Acting |
| D061386 | Insulin, Regular, Human |
| D061266 | Insulin, Short-Acting |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D054833 | Isoindoles |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D001552 | Benzazepines |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D013777 | Tetrazoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000601 | Amino Acids, Essential |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D015016 | Yohimbine |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010793 | Phthalazines |
| D011724 | Pyridazines |
| D002227 | Carbazoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011621 | Pteridines |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Canada |
|
| No history of CVD event |
|
| Diastolic |
|
| HDL |
|
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|
|
|
|
|
|
|
|
| Participants |
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|