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| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
| LifeScan | INDUSTRY |
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The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical therapy | No Intervention | Intensive medical therapy for diabetes | |
| Gastric Bypass | Active Comparator | Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy |
|
| Sleeve Gastrectomy | Active Comparator | Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | Roux-en-Y gastric bypass |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. | The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure). | 1 year |
| Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications | The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance). | 1, 2, and 5 years | |
| Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations. | 1, 2, and 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip R Schauer, MD | Director, Bariatric and Metabolic Institute, Cleveland Clinic Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16670131 | Background | O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005. | |
| 14530719 |
Not provided
Not provided
68 patients screened fail prior to randomization due to not meeting inclusion criteria.
Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Medical Therapy | Intensive medical therapy for diabetes |
| FG001 | Gastric Bypass | Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy |
| FG002 | Sleeve Gastrectomy | Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 Year Follow-up |
|
| |||||||||||||||||||||
| 2 Year Sub-study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Medical Therapy | Intensive medical therapy for diabetes |
| BG001 | Gastric Bypass | Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. | The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure). | Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
1 year
Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred.
Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization.
1 Sleeve Gastrectomy subject withdrew prior to surgery.
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 | Medical Therapy | Intensive medical therapy for diabetes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intravenous treatment for dehydration | Surgical and medical procedures | Systematic Assessment | Intravenous treatment for dehydration requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV Treatment for Dehydration | Surgical and medical procedures | Systematic Assessment |
Important limitations in the primary endpoint and 1 year outcomes are the short duration of follow-up (12 months), the study occurred at a single-center and the open-label nature of the study (subjects were not blinded to treatment).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Schauer | Cleveland Clinic | 216-444-4794 | schauep@ccf.org |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sleeve Gastrectomy | Procedure | Laparoscopic sleeve gastrectomy |
|
|
| The Cost-effectiveness of Each Program and the Side Effects and /or Complications. | 1, 2, and 5 years. |
| Change in Glycated Hemoglobin (HbA1c) | Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change | 1 year - baseline |
| Fasting Plasma Glucose | Fasting Plasma Glucose measured in mg/dL. | 1 year |
| Glycated Hemoglobin (HbA1c) | Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points | 1 year |
| Body Weight | Body weight in kilograms (kg) measured at 12 months | 1 year |
| Change in Body Weight From Baseline | Mean change in body weight from baseline measured in kilograms (kg) | 1 year |
| Body Mass Index (BMI) | Body Mass Index (BMI) at 12 months measured as kg/m2 | 1 year |
| Change in Body Mass Index (BMI) | Change in Body Mass Index (BMI) at 12 months, measured in kg/m2 | 1 year |
| Change in Systolic Blood Pressure (SBP) | Change in Systolic Blood Pressure (SBP) at 12 months | 1 year |
| Change in High-density Lipoprotein (HDL) | Percent change in high-density lipoprotein (HDL) at 12 months | 1 year |
| Change in Triglycerides | Median percent change in triglycerides at 12 months from baseline measure | 1 year |
| Change in High-sensitivity C-reactive Protein (Hs-CRP) | Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months | 1 year |
| Diabetes Medication - Use of Insulin | Number of participants taking insulin at 12 months | 1 year |
| Diabetes Medication - Use of Biguanides | Number of participants taking Biguanides at 12 months | 1 year |
| Diabetes Medication - Use of Thiazolidinedione | Number of participants using thiazolidinedione at 12 months | 1 year |
| Diabetes Medication - Use of Incretin Mimetics | Number of participants taking Incretin Mimetics | 1 year |
| Diabetes Medication - Use of Secretagogue | Number of participants taking Secretagogues at 12 months | 1 year |
| Cardiovascular Medications - Lipid Lowering Agents | Number of participants taking Lipid lowering agents at 12 months | 1 year |
| Cardiovascular Medications - Beta Blocker | Number of participants taking Beta Blockers at 12 months | 1 year |
| Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) | Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months | 1 year |
| Cardiovascular Medications - Anticoagulants | Number of participants taking anticoagulants at 12 months | 1 year |
| Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b. |
| 17128540 | Background | Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993. |
| 9742976 | Background | Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. |
| 9571335 | Background | Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518. |
| 12397193 | Background | Nathan DM. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N Engl J Med. 2002 Oct 24;347(17):1342-9. doi: 10.1056/NEJMcp021106. No abstract available. |
| 7622004 | Background | The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes. 1995 Aug;44(8):968-83. |
| 12610059 | Background | Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917. |
| 28199805 | Derived | Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869. |
| 24679060 | Derived | Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. N Engl J Med. 2014 May 22;370(21):2002-13. doi: 10.1056/NEJMoa1401329. Epub 2014 Mar 31. |
| 23439632 | Derived | Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Aug;36(8):2175-82. doi: 10.2337/dc12-1596. Epub 2013 Feb 25. |
| 22449319 | Derived | Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26. |
| NOT COMPLETED |
|
| BG002 | Sleeve Gastrectomy | Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants self reported race/ethnicity according to Caucasian, Black/African American, Asian, Hispanic/Latino, American Indian/Alaska Native, Pacific Islander, or Other. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of diabetes | Mean | Standard Deviation | Years |
|
| Use of insulin | Number | participants |
|
| body-mass index | Mean | Standard Deviation | kg/m2 |
|
| Body-mass index < 35 | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| Smoker | Number | Participants |
|
| Metabolic syndrome | Number | participants |
|
| History of dyslipidemia | Number | participants |
|
| History of hypertension | Number | participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| High-density lipoprotein cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Median | Inter-Quartile Range | mg/dL |
|
| Diabetic medication - Biguanides | Number | participants |
|
| Diabetes medication - Thiazolidinedione (TZD's) | Number | participants |
|
| Diabetes medication - Incretin Mimetics | Number | participants |
|
| Diabetes medication - Secretagogues | Number | participants |
|
| Number of Diabetic Medications | Number | participants |
|
| Cardiovascular medication - Lipid Lowering Agents | Number | participants |
|
| Cardiovascular medication - Beta blocker | Number | participant |
|
| Cardiovascular medications - ACE Inhibitors or ARB | Number | participant |
|
| Cardiovascular medication - Anticoagulant | Number | participant |
|
Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy |
| OG002 | Sleeve Gastrectomy | Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy |
|
|
|
| Secondary | Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance). | Not Posted | 1, 2, and 5 years | Participants |
| Secondary | Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations. | Not Posted | 1, 2, and 5 years | Participants |
| Secondary | The Cost-effectiveness of Each Program and the Side Effects and /or Complications. | Not Posted | 1, 2, and 5 years. | Participants |
| Secondary | Change in Glycated Hemoglobin (HbA1c) | Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | percentage points of glycated hemoglobin | 1 year - baseline |
|
|
|
|
| Secondary | Fasting Plasma Glucose | Fasting Plasma Glucose measured in mg/dL. | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Median | Inter-Quartile Range | mg/dL | 1 year |
|
|
|
|
| Secondary | Glycated Hemoglobin (HbA1c) | Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | percentage points of glycated hemoglobin | 1 year |
|
|
|
|
| Primary | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications | The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization. | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Body Weight | Body weight in kilograms (kg) measured at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | kg | 1 year |
|
|
|
|
| Secondary | Change in Body Weight From Baseline | Mean change in body weight from baseline measured in kilograms (kg) | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | kg | 1 year |
|
|
|
|
| Secondary | Body Mass Index (BMI) | Body Mass Index (BMI) at 12 months measured as kg/m2 | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | kg/m2 | 1 year |
|
|
|
|
| Secondary | Change in Body Mass Index (BMI) | Change in Body Mass Index (BMI) at 12 months, measured in kg/m2 | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | kg/m2 | 1 year |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) | Change in Systolic Blood Pressure (SBP) at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | mm Hg | 1 year |
|
|
|
|
| Secondary | Change in High-density Lipoprotein (HDL) | Percent change in high-density lipoprotein (HDL) at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Mean | Standard Deviation | mg/dL | 1 year |
|
|
|
|
| Secondary | Change in Triglycerides | Median percent change in triglycerides at 12 months from baseline measure | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Median | Inter-Quartile Range | mg/dL | 1 year |
|
|
|
|
| Secondary | Change in High-sensitivity C-reactive Protein (Hs-CRP) | Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Median | Inter-Quartile Range | mg/L | 1 year |
|
|
|
|
| Secondary | Diabetes Medication - Use of Insulin | Number of participants taking insulin at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Diabetes Medication - Use of Biguanides | Number of participants taking Biguanides at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Diabetes Medication - Use of Thiazolidinedione | Number of participants using thiazolidinedione at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Diabetes Medication - Use of Incretin Mimetics | Number of participants taking Incretin Mimetics | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Diabetes Medication - Use of Secretagogue | Number of participants taking Secretagogues at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Cardiovascular Medications - Lipid Lowering Agents | Number of participants taking Lipid lowering agents at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Cardiovascular Medications - Beta Blocker | Number of participants taking Beta Blockers at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) | Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| Secondary | Cardiovascular Medications - Anticoagulants | Number of participants taking anticoagulants at 12 months | Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis. | Posted | Number | participants | 1 year |
|
|
|
|
| 4 |
| 43 |
| 42 |
| 43 |
| EG001 | Gastric Bypass | Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy | 16 | 50 | 48 | 50 |
| EG002 | Sleeve Gastrectomy | Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy | 7 | 49 | 49 | 49 |
|
| Reoperation | Surgical and medical procedures | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | Systematic Assessment |
|
| Hemoglobin decrease > / = 5 g/dl | Investigations | Systematic Assessment |
|
| Gastrointestinal leak | Surgical and medical procedures | Systematic Assessment |
|
| Transient renal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Arrhythmia or palpitations | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ketoacidosis | Endocrine disorders | Systematic Assessment |
|
| Wound infection | Surgical and medical procedures | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Hernia | Surgical and medical procedures | Systematic Assessment |
|
| Reflux Disease - GERD | Surgical and medical procedures | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fatty Liver | Hepatobiliary disorders | Systematic Assessment |
|
| Infection Not Requiring Antibiotics | Infections and infestations | Systematic Assessment |
|
| Infections Requiring Antibiotics | Infections and infestations | Systematic Assessment |
|
| Viral Flu | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hand pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
| Vertigo / Dizziness | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| UTI (Urinary Tract Infection) | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection - Bacterial | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection - Viral | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alopecia / hair loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| 95 |
| Superiority or Other |
| ANOVA | 0.85 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.86 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.23 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.10 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.02 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.02 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.61 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.03 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.46 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| ANOVA | 0.98 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.17 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.59 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.68 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.05 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.06 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.004 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.20 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.20 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.06 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.62 | 95 | Superiority or Other |
| 95 |
| Superiority or Other |
| Chi-squared | 0.03 | 95 | Superiority or Other |