Obesity Clinical Trial
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
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.
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
;
Observational Model: Cohort, Time Perspective: Prospective
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