Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes

Study Overview
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Brief Summary
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Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of Roux-en-Y gastric bypass is more effective than the Adjustable Gastric Band on weight loss. This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the responsible mechanisms. The evaluation will be made preoperatively and 1 year later as assessed by the decline in HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.

Detailed Description
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Type 2 diabetes is a condition often associated with obesity and often difficult to control. In patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. In most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. Among the various technical options, adjustable gastric band (AGB) is the simplest and by far the most used in France. Roux-en-Y gastric bypass (RYGB) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. Several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. No study controlled, however, has compared these two techniques. The objective of this study is to compare the efficiency of RYGB vs AGB on glycemic control in type 2 diabetes. Although some studies have compared AGB and RYGB, none have compared their effectiveness on post prandial glucose control in patients with diabetes. It is generally recognized that the effectiveness of RYGB on diabetes is independent of the weight loss, but this has never been demonstrated. By demonstrating the superiority of RYGB vs AGB, and identifying the responsible mechanisms, the study will expand the indications of RYGB in the treatment of type 2 diabetes. Weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes. Main objective: To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes. Secondary Objectives: demonstrate that the better outcome achieved with RYGB is independent of weight loss. Identify the mechanisms underlying the better outcome of RYGB

Official Title
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Longitudinal Cohort Study Comparing 2 Surgical Techniques (Roux-en-Y Gastric Bypass and Adjustable Gastric Banding) in Patients With Class 3 Obesity and Type 2 Diabetes

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Procedure: Roux-en-Y gastric bypass
* Procedure: Adjustable gastric band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 years AND BMI > 35 Type 2 diabetes Obesity for more than 5 years OR normoglycemia BMI< 30 Exclusion Criteria: Secondary obesity due to an endocrinopathy Chronic pathology (neoplasia, cirrhosis, disease of system) Psychosis, alcoholic addiction or narcotics. Contre-indications to the anaesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roux-en-Y gastric bypass<br>Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass | Procedure: Roux-en-Y gastric bypass<br>* Laparoscopic Roux-en-Y gastric bypass<br>* Other names: Gastric bypass;|
| Adjustable gastric banding<br>Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding | Procedure: Adjustable gastric band<br>* Laparoscopic adjustable gastric band<br>* Other names: Gastric Banding;|
| Healthy controls<br>Non-obese, non-diabetic adults | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control | HbA1c and fasting blood glucose | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss | Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test | 3 months | 
| Weight loss | Body mass index | 60 months | 
| Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal | Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test | 12 months | 
| Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal | Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test | 60 months | 
| Diabetes remission | HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, obesity, gastric bypass, adjustable gastric banding, BMI > 35., obesity for more than 5 years