Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes (OBEDIAB)
|ClinicalTrials.gov Identifier: NCT00688974|
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : August 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes||Procedure: Roux-en-Y gastric bypass Procedure: Adjustable gastric band||Phase 2 Phase 3|
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.
- To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes.
- demonstrate that the better outcome achieved with RYGB is independent of weight loss.
- Identify the mechanisms underlying the better outcome of RYGB
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Official Title:||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|
|Study Start Date :||May 2004|
|Primary Completion Date :||November 2006|
|Study Completion Date :||September 2012|
Roux-en-Y gastric bypass
Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
Procedure: Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
Other Name: Gastric bypass
Adjustable gastric banding
Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
Procedure: Adjustable gastric band
Laparoscopic adjustable gastric band
Other Name: Gastric Banding
Non-obese, non-diabetic adults
- Glucose control [ Time Frame: 12 months ]HbA1c and fasting blood glucose
- Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss [ Time Frame: 3 months ]Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
- Weight loss [ Time Frame: 60 months ]Body mass index
- Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal [ Time Frame: 12 months ]Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
- Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal [ Time Frame: 60 months ]Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
- Diabetes remission [ Time Frame: 60 months ]HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688974
|Lille University Hospital|
|Lille, Nord, France, 59037|
|Principal Investigator:||Francois PATTOU||Lille University Hospital|