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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK119913-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with diabetes such as fatty liver disease.
Investigators propose that high iron triggers a number of events in different tissues, some of which will predispose to diabetes. Investigators will therefore study normal individuals who have higher than average iron levels in tissues, test your glucose control through standard blood tests like the hemoglobin A1c and by placing a continuous glucose monitor before and after participants have donated blood to determine if decreasing iron levels had any effect.
In addition, iron may also play a role in the progression of fatty liver to scarring and cirrhosis. Since 75% of people with diabetes have some degree of fatty liver, investigators would also like to study how the liver reacts to the lowering of iron.
There will be two optional sub studies conducted only at Wake Forest University Health Sciences they are: 1) Liver substudy that will look at liver complication of diabetes and the role it plays in the progression of fatty liver to scarring and cirrhosis. Investigators will look at how liver reacts to the lowering of iron. 2)Glucose Tolerance Mechanism substudy that will look at the mechanism the body uses to regulate blood sugar levels by insulin, this will require the frequently sample intravenous glucose tolerance test (FSIVGTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy |
|
| Control Group | Sham Comparator | Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Donation | Procedure | Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed. |
| Measure | Description | Time Frame |
|---|---|---|
| HgbA1c Value | HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported. | Baseline |
| HgbA1c Value | HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported. | month 6 |
| ALT (Alanine Aminotransferase) Value | An ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported. | Baseline |
| ALT Value | An ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported. | month 12 |
| FSIGTT DI (Frequently Sampled Intravenous Glucose Tolerance Test) Value | Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin. | Baseline |
| FSIGTT DI Value | Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin. |
| Measure | Description | Time Frame |
|---|---|---|
| HgbA1c Value at Month 12 | HgbA1c measures average blood glucose levels over the past 2-3 months. | Month 12 |
| Change in Fasting Glucose | Fasting glucose measured on glucose machine (Abbott Freestyle Libre Pro system). Difference in values from baseline through month 6 and baseline through month 12 will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald A McClain, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill (UNC) | Chapel Hill | North Carolina | 27599-2100 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9342544 | Background | Buysschaert M, Paris I, Selvais P, Hermans MP. Clinical aspects of diabetes secondary to idiopathic haemochromatosis in French-speaking Belgium. Diabetes Metab. 1997 Sep;23(4):308-13. | |
| 17019598 | Background | Abraham D, Rogers J, Gault P, Kushner JP, McClain DA. Increased insulin secretory capacity but decreased insulin sensitivity after correction of iron overload by phlebotomy in hereditary haemochromatosis. Diabetologia. 2006 Nov;49(11):2546-51. doi: 10.1007/s00125-006-0445-7. Epub 2006 Sep 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed. |
| FG001 | Control Group | Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | HgbA1c Value | HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported. | Posted | Mean | Standard Deviation | percentage of HgbA1c | Baseline |
|
from baseline through month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy Blood Donation: Participants in the TREATMENT GROUP will have a Unit of blood (two cups, the same amount you would donate at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure blood count to be sure participants are not anemic, and blood pressure to be sure there is no dehydration. During or after donation, participants will be given a sports drink to replace the fluid loss. Participants in the CONTROL GROUP will not donate blood, but will have a needle inserted into a vein in your arm. Neither group will not know to which they have been assigned, all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so they will not know whether blood was actually removed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Don McClain, PhD | Atrium Health Wake Forest Baptist | 801-550-2905 | donald.mcclain@advocatehealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2025 | Apr 20, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2024 | Mar 26, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000094345 | Blood Donation |
| ID | Term |
|---|---|
| D009927 | Tissue and Organ Procurement |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Both groups will not know assignment as all will have a sleep mask (like a blindfold, covering the eyes, held on with an elastic band) placed so participant will not know whether blood was actually removed.
|
| Sham Blood Donation | Procedure | Participants will have a needle inserted their arm, however, no blood will be drawn. |
|
| month 6 |
| Month 6, Month 12 |
| HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) Score | Insulin sensitivity measured by HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) calculated from fasting glucose and insulin. Values will be reported for Baseline and 12 months. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a calculated score that uses fasting insulin and glucose to measure insulin resistance. An optimal score is generally below 1.0, while values above 1.9 suggest early insulin resistance, and those above 2.9 indicate significant insulin resistance. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) measures insulin resistance by multiplying fasting insulin and fasting glucose, then dividing by 405. A score below 1.0 indicates optimal insulin sensitivity, while above 1.9-2.0 suggests early resistance, and above 2.9 indicates significant resistance. | baseline, month 12 |
| Number of Participants That Discontinued of Oral Antihyperglycemic Agent | The numbers of participants that discontinued of oral antihyperglycemic agents | Month 12 |
| Change in Weight | The change in weight from baseline to month 12 will be reported | Baseline, Month 12 |
| Change in Systolic Blood Pressure | The change in systolic Blood pressure from baseline to month 12 will be reported | Baseline, Month 12 |
| Number of Participants That Converted From Pre-diabetes to Diabetes | Number of participants that converted from pre-Diabetes to Diabetes based on the HbA1C criteria. | Month 12 |
| Number of Participants That Converted From Pre-diabetes to Normal Glucose Tolerance | Number of participants that converted from pre-Diabetes to normal glucose tolerance based on the HbA1C criteria. | Month 12 |
| Wake Forest University Health Sciences |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| 11087882 | Background | Bulaj ZJ, Ajioka RS, Phillips JD, LaSalle BA, Jorde LB, Griffen LM, Edwards CQ, Kushner JP. Disease-related conditions in relatives of patients with hemochromatosis. N Engl J Med. 2000 Nov 23;343(21):1529-35. doi: 10.1056/NEJM200011233432104. |
| 8345055 | Background | Dmochowski K, Finegood DT, Francombe W, Tyler B, Zinman B. Factors determining glucose tolerance in patients with thalassemia major. J Clin Endocrinol Metab. 1993 Aug;77(2):478-83. doi: 10.1210/jcem.77.2.8345055. |
| 10587829 | Background | Ford ES, Cogswell ME. Diabetes and serum ferritin concentration among U.S. adults. Diabetes Care. 1999 Dec;22(12):1978-83. doi: 10.2337/diacare.22.12.1978. |
| 14871914 | Background | Jiang R, Manson JE, Meigs JB, Ma J, Rifai N, Hu FB. Body iron stores in relation to risk of type 2 diabetes in apparently healthy women. JAMA. 2004 Feb 11;291(6):711-7. doi: 10.1001/jama.291.6.711. |
| 12450906 | Background | Fleming DJ, Tucker KL, Jacques PF, Dallal GE, Wilson PW, Wood RJ. Dietary factors associated with the risk of high iron stores in the elderly Framingham Heart Study cohort. Am J Clin Nutr. 2002 Dec;76(6):1375-84. doi: 10.1093/ajcn/76.6.1375. |
| 18413178 | Background | Afkhami-Ardekani M, Rashidi M. Iron status in women with and without gestational diabetes mellitus. J Diabetes Complications. 2009 May-Jun;23(3):194-8. doi: 10.1016/j.jdiacomp.2007.11.006. Epub 2008 Apr 16. |
| 12811229 | Background | Wilson JG, Lindquist JH, Grambow SC, Crook ED, Maher JF. Potential role of increased iron stores in diabetes. Am J Med Sci. 2003 Jun;325(6):332-9. doi: 10.1097/00000441-200306000-00004. |
| 21709295 | Background | Qiu C, Zhang C, Gelaye B, Enquobahrie DA, Frederick IO, Williams MA. Gestational diabetes mellitus in relation to maternal dietary heme iron and nonheme iron intake. Diabetes Care. 2011 Jul;34(7):1564-9. doi: 10.2337/dc11-0135. |
| 21709294 | Background | Bowers K, Yeung E, Williams MA, Qi L, Tobias DK, Hu FB, Zhang C. A prospective study of prepregnancy dietary iron intake and risk for gestational diabetes mellitus. Diabetes Care. 2011 Jul;34(7):1557-63. doi: 10.2337/dc11-0134. |
| 18398807 | Background | Sharifi F, Nasab NM, Zadeh HJ. Elevated serum ferritin concentrations in prediabetic subjects. Diab Vasc Dis Res. 2008 Mar;5(1):15-8. doi: 10.3132/dvdr.2008.003. |
| 15451911 | Background | Jehn M, Clark JM, Guallar E. Serum ferritin and risk of the metabolic syndrome in U.S. adults. Diabetes Care. 2004 Oct;27(10):2422-8. doi: 10.2337/diacare.27.10.2422. |
| 11513189 | Background | Fargion S, Mattioli M, Fracanzani AL, Sampietro M, Tavazzi D, Fociani P, Taioli E, Valenti L, Fiorelli G. Hyperferritinemia, iron overload, and multiple metabolic alterations identify patients at risk for nonalcoholic steatohepatitis. Am J Gastroenterol. 2001 Aug;96(8):2448-55. doi: 10.1111/j.1572-0241.2001.04052.x. |
| 19387120 | Background | Altamura S, Muckenthaler MU. Iron toxicity in diseases of aging: Alzheimer's disease, Parkinson's disease and atherosclerosis. J Alzheimers Dis. 2009;16(4):879-95. doi: 10.3233/JAD-2009-1010. |
| 19018762 | Background | Toyokuni S. Role of iron in carcinogenesis: cancer as a ferrotoxic disease. Cancer Sci. 2009 Jan;100(1):9-16. doi: 10.1111/j.1349-7006.2008.01001.x. Epub 2008 Oct 23. |
| 22986645 | Background | Zhang W, Iso H, Ohira T, Date OC, Tanabe N, Kikuchi S, Tamakoshi A. Associations of dietary iron intake with mortality from cardiovascular disease: the JACC study. J Epidemiol. 2012;22(6):484-93. doi: 10.2188/jea.je20120006. Epub 2012 Sep 15. |
| 17333112 | Background | Forouhi NG, Harding AH, Allison M, Sandhu MS, Welch A, Luben R, Bingham S, Khaw KT, Wareham NJ. Elevated serum ferritin levels predict new-onset type 2 diabetes: results from the EPIC-Norfolk prospective study. Diabetologia. 2007 May;50(5):949-56. doi: 10.1007/s00125-007-0604-5. Epub 2007 Mar 2. |
| 18996855 | Background | Fargnoli JL, Fung TT, Olenczuk DM, Chamberland JP, Hu FB, Mantzoros CS. Adherence to healthy eating patterns is associated with higher circulating total and high-molecular-weight adiponectin and lower resistin concentrations in women from the Nurses' Health Study. Am J Clin Nutr. 2008 Nov;88(5):1213-24. doi: 10.3945/ajcn.2008.26480. |
| 22996660 | Background | Gabrielsen JS, Gao Y, Simcox JA, Huang J, Thorup D, Jones D, Cooksey RC, Gabrielsen D, Adams TD, Hunt SC, Hopkins PN, Cefalu WT, McClain DA. Adipocyte iron regulates adiponectin and insulin sensitivity. J Clin Invest. 2012 Oct;122(10):3529-40. doi: 10.1172/JCI44421. Epub 2012 Sep 10. |
| 20354157 | Background | Cooksey RC, Jones D, Gabrielsen S, Huang J, Simcox JA, Luo B, Soesanto Y, Rienhoff H, Abel ED, McClain DA. Dietary iron restriction or iron chelation protects from diabetes and loss of beta-cell function in the obese (ob/ob lep-/-) mouse. Am J Physiol Endocrinol Metab. 2010 Jun;298(6):E1236-43. doi: 10.1152/ajpendo.00022.2010. Epub 2010 Mar 30. |
| 22647517 | Background | Houschyar KS, Ludtke R, Dobos GJ, Kalus U, Broecker-Preuss M, Rampp T, Brinkhaus B, Michalsen A. Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome: results from a randomized clinical trial. BMC Med. 2012 May 30;10:54. doi: 10.1186/1741-7015-10-54. |
| 11916918 | Background | Fernandez-Real JM, Penarroja G, Castro A, Garcia-Bragado F, Hernandez-Aguado I, Ricart W. Blood letting in high-ferritin type 2 diabetes: effects on insulin sensitivity and beta-cell function. Diabetes. 2002 Apr;51(4):1000-4. doi: 10.2337/diabetes.51.4.1000. |
| 26301810 | Background | Gao Y, Li Z, Gabrielsen JS, Simcox JA, Lee SH, Jones D, Cooksey B, Stoddard G, Cefalu WT, McClain DA. Adipocyte iron regulates leptin and food intake. J Clin Invest. 2015 Sep;125(9):3681-91. doi: 10.1172/JCI81860. Epub 2015 Aug 24. |
| 22961109 | Background | Kusminski CM, Holland WL, Sun K, Park J, Spurgin SB, Lin Y, Askew GR, Simcox JA, McClain DA, Li C, Scherer PE. MitoNEET-driven alterations in adipocyte mitochondrial activity reveal a crucial adaptive process that preserves insulin sensitivity in obesity. Nat Med. 2012 Oct;18(10):1539-49. doi: 10.1038/nm.2899. Epub 2012 Sep 9. |
| 21953442 | Background | Kowdley KV, Belt P, Wilson LA, Yeh MM, Neuschwander-Tetri BA, Chalasani N, Sanyal AJ, Nelson JE; NASH Clinical Research Network. Serum ferritin is an independent predictor of histologic severity and advanced fibrosis in patients with nonalcoholic fatty liver disease. Hepatology. 2012 Jan;55(1):77-85. doi: 10.1002/hep.24706. Epub 2011 Dec 6. |
| 19931264 | Background | Valenti L, Fracanzani AL, Bugianesi E, Dongiovanni P, Galmozzi E, Vanni E, Canavesi E, Lattuada E, Roviaro G, Marchesini G, Fargion S. HFE genotype, parenchymal iron accumulation, and liver fibrosis in patients with nonalcoholic fatty liver disease. Gastroenterology. 2010 Mar;138(3):905-12. doi: 10.1053/j.gastro.2009.11.013. Epub 2009 Nov 18. |
| 20027673 | Background | Duvnjak M, Barsic N, Tomasic V, Lerotic I. Genetic polymorphisms in non-alcoholic fatty liver disease: clues to pathogenesis and disease progression. World J Gastroenterol. 2009 Dec 28;15(48):6023-7. doi: 10.3748/wjg.15.6023. |
| 24756010 | Background | Beaton MD, Chakrabarti S, Adams PC. Inflammation is not the cause of an elevated serum ferritin in non-alcoholic fatty liver disease. Ann Hepatol. 2014 May-Jun;13(3):353-6. |
| 24659891 | Background | Valenti L, Fracanzani AL, Dongiovanni P, Rovida S, Rametta R, Fatta E, Pulixi EA, Maggioni M, Fargion S. A randomized trial of iron depletion in patients with nonalcoholic fatty liver disease and hyperferritinemia. World J Gastroenterol. 2014 Mar 21;20(11):3002-10. doi: 10.3748/wjg.v20.i11.3002. |
| 21718726 | Background | Dongiovanni P, Fracanzani AL, Fargion S, Valenti L. Iron in fatty liver and in the metabolic syndrome: a promising therapeutic target. J Hepatol. 2011 Oct;55(4):920-32. doi: 10.1016/j.jhep.2011.05.008. Epub 2011 Jun 28. |
| 28593739 | Background | Murali AR, Gupta A, Brown K. Systematic review and meta-analysis to determine the impact of iron depletion in dysmetabolic iron overload syndrome and non-alcoholic fatty liver disease. Hepatol Res. 2018 Feb;48(3):E30-E41. doi: 10.1111/hepr.12921. Epub 2017 Jul 20. |
| 25524401 | Background | Adams LA, Crawford DH, Stuart K, House MJ, St Pierre TG, Webb M, Ching HL, Kava J, Bynevelt M, MacQuillan GC, Garas G, Ayonrinde OT, Mori TA, Croft KD, Niu X, Jeffrey GP, Olynyk JK. The impact of phlebotomy in nonalcoholic fatty liver disease: A prospective, randomized, controlled trial. Hepatology. 2015 May;61(5):1555-64. doi: 10.1002/hep.27662. Epub 2015 Mar 20. |
| 20805282 | Background | Lorenzo C, Wagenknecht LE, Rewers MJ, Karter AJ, Bergman RN, Hanley AJ, Haffner SM. Disposition index, glucose effectiveness, and conversion to type 2 diabetes: the Insulin Resistance Atherosclerosis Study (IRAS). Diabetes Care. 2010 Sep;33(9):2098-103. doi: 10.2337/dc10-0165. |
| 11568090 | Background | Koziol JA, Ho NJ, Felitti VJ, Beutler E. Reference centiles for serum ferritin and percentage of transferrin saturation, with application to mutations of the HFE gene. Clin Chem. 2001 Oct;47(10):1804-10. |
| 21981048 | Background | Cheng HL, Bryant C, Cook R, O'Connor H, Rooney K, Steinbeck K. The relationship between obesity and hypoferraemia in adults: a systematic review. Obes Rev. 2012 Feb;13(2):150-61. doi: 10.1111/j.1467-789X.2011.00938.x. Epub 2011 Oct 10. |
| 18719644 | Background | Ausk KJ, Ioannou GN. Is obesity associated with anemia of chronic disease? A population-based study. Obesity (Silver Spring). 2008 Oct;16(10):2356-61. doi: 10.1038/oby.2008.353. Epub 2008 Jul 24. |
| 25238834 | Background | Andrews Guzman M, Arredondo Olguin M. Association between ferritin, high sensitivity C-reactive protein (hsCRP) and relative abundance of Hepcidin mRNA with the risk of type 2 diabetes in obese subjects. Nutr Hosp. 2014 Sep 1;30(3):577-84. doi: 10.3305/nh.2014.30.3.7647. |
| 11832527 | Background | Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. |
| 11978935 | Background | Beutler E, Felitti V, Ho NJ, Gelbart T. Relationship of body iron stores to levels of serum ferritin, serum iron, unsaturated iron binding capacity and transferrin saturation in patients with iron storage disease. Acta Haematol. 2002;107(3):145-9. doi: 10.1159/000057632. |
| Adverse Event |
|
| BG001 | Control Group | Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn. |
|
|
| Primary | HgbA1c Value | HgbA1c measures average blood glucose levels over the past 2-3 months. HgbA1C values from baseline and month 6 will be reported. | Posted | Mean | Standard Deviation | percentage of HgbA1c | month 6 |
|
|
|
| Primary | ALT (Alanine Aminotransferase) Value | An ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported. | Posted | Mean | Standard Deviation | IU/L | Baseline |
|
|
|
| Primary | ALT Value | An ALT test measures a liver enzyme. ALT values from baseline and month 12 will be reported. | Posted | Mean | Standard Deviation | IU/L | month 12 |
|
|
|
| Primary | FSIGTT DI (Frequently Sampled Intravenous Glucose Tolerance Test) Value | Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin. | Only a few participants were able to donate for this outcome because the lab closed due to COVID--it was not collected at the same visit as all other baseline labs. | Posted | Mean | Standard Deviation | Si*AIRg | Baseline |
|
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| Primary | FSIGTT DI Value | Studies often report DI values with a wide range. Normal or reference ranges can vary substantially depending on the study. Higher values indicate better -cell function. The Disposition Index (DI) derived from the Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) is a measure of pancreatic -cell function, calculated as the product of insulin sensitivity (S1) and the acute insulin response to glucose (AIRg). It acts as a marker for how well insulin secretion compensates for insulin. | Only a few participants were able to donate for this outcome because the lab closed due to COVID--it was not collected at the same visit as all other month 6 labs. | Posted | Mean | Standard Deviation | Si*AIRg | month 6 |
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| Secondary | HgbA1c Value at Month 12 | HgbA1c measures average blood glucose levels over the past 2-3 months. | Posted | Mean | Standard Deviation | % of HgbA1c | Month 12 |
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| Secondary | Change in Fasting Glucose | Fasting glucose measured on glucose machine (Abbott Freestyle Libre Pro system). Difference in values from baseline through month 6 and baseline through month 12 will be reported. | Posted | Mean | Standard Deviation | mg/dL | Month 6, Month 12 |
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| Secondary | HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) Score | Insulin sensitivity measured by HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) calculated from fasting glucose and insulin. Values will be reported for Baseline and 12 months. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a calculated score that uses fasting insulin and glucose to measure insulin resistance. An optimal score is generally below 1.0, while values above 1.9 suggest early insulin resistance, and those above 2.9 indicate significant insulin resistance. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) measures insulin resistance by multiplying fasting insulin and fasting glucose, then dividing by 405. A score below 1.0 indicates optimal insulin sensitivity, while above 1.9-2.0 suggests early resistance, and above 2.9 indicates significant resistance. | Not collected in all participants | Posted | Mean | Standard Deviation | score on a scale | baseline, month 12 |
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| Secondary | Number of Participants That Discontinued of Oral Antihyperglycemic Agent | The numbers of participants that discontinued of oral antihyperglycemic agents | Posted | Count of Participants | Participants | Month 12 |
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| Secondary | Change in Weight | The change in weight from baseline to month 12 will be reported | Posted | Mean | Standard Deviation | pounds | Baseline, Month 12 |
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| Secondary | Change in Systolic Blood Pressure | The change in systolic Blood pressure from baseline to month 12 will be reported | Posted | Mean | Standard Deviation | mmHG | Baseline, Month 12 |
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| Secondary | Number of Participants That Converted From Pre-diabetes to Diabetes | Number of participants that converted from pre-Diabetes to Diabetes based on the HbA1C criteria. | Posted | Count of Participants | Participants | Month 12 |
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| Secondary | Number of Participants That Converted From Pre-diabetes to Normal Glucose Tolerance | Number of participants that converted from pre-Diabetes to normal glucose tolerance based on the HbA1C criteria. | Posted | Count of Participants | Participants | Month 12 |
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| 0 |
| 64 |
| 1 |
| 64 |
| 12 |
| 64 |
| EG001 | Control Group | Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy Sham Blood Donation: Participants will have a needle inserted their arm, however, no blood will be drawn. | 1 | 68 | 3 | 68 | 9 | 68 |
| Kidney Stone Surgery | Surgical and medical procedures | Systematic Assessment |
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| E.coli | Infections and infestations | Systematic Assessment |
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| Insulin Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Broken Ankle | Injury, poisoning and procedural complications | Systematic Assessment |
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| Left Arm Soreness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cataract Surgery | Surgical and medical procedures | Systematic Assessment |
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| carpometacarpal joint surgery | Surgical and medical procedures | Systematic Assessment |
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| Common Cold | Infections and infestations | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye Surgery | Surgical and medical procedures | Systematic Assessment |
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| Hemorrhoids | General disorders | Systematic Assessment |
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| Hip pain | General disorders | Systematic Assessment |
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| Leg Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| sleep apnea | General disorders | Systematic Assessment |
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| right achilles tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Right Knee Pain | General disorders | Systematic Assessment |
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| Right Knee Replacement Surgery | Surgical and medical procedures | Systematic Assessment |
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| Sciatica | General disorders | Systematic Assessment |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
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| Toe Surgery | Surgical and medical procedures | Systematic Assessment |
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| Ulnar Nerve Surgery | Surgical and medical procedures | Systematic Assessment |
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Not provided
Not provided
Not provided
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |