Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Procedure: Gastric bypass
* Procedure: Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus with HbA1c > 7.0% Body mass index > 27 and < 43 kg/m2 Candidate for general anesthesia Exclusion Criteria: Prior bariatric surgery of any kind Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl Known history of chronic liver disease (except for NAFLD/NASH) Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months Severe pulmonary disease defined as FEV1 < 50% of predicted value Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical therapy<br>Intensive medical therapy for diabetes | |
| Active Comparator: Gastric Bypass<br>Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy | Procedure: Gastric bypass<br>* Roux-en-Y gastric bypass<br>* Other names: RYGB;|
| Active Comparator: Sleeve Gastrectomy<br>Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy | Procedure: Sleeve Gastrectomy<br>* Laparoscopic sleeve gastrectomy<br>* Other names: SG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Obesity