Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes
NCT ID: NCT00688974
Last Updated: 2016-08-18
Study Results
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Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2004-05-31
2012-09-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Roux-en-Y gastric bypass
Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
Adjustable gastric banding
Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
Adjustable gastric band
Laparoscopic adjustable gastric band
Healthy controls
Non-obese, non-diabetic adults
No interventions assigned to this group
Interventions
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Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
Adjustable gastric band
Laparoscopic adjustable gastric band
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \> 35
* Type 2 diabetes
* Obesity for more than 5 years OR
* normoglycemia
* BMI\< 30
Exclusion Criteria
* Chronic pathology (neoplasia, cirrhosis, disease of system)
* Psychosis, alcoholic addiction or narcotics.
* Contre-indications to the anaesthesia
18 Years
70 Years
ALL
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Francois PATTOU
Role: PRINCIPAL_INVESTIGATOR
Lille University Hospital
Locations
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Lille University Hospital
Lille, Nord, France
Countries
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Other Identifiers
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2004/0412
Identifier Type: OTHER
Identifier Source: secondary_id
DGS 2004/0123
Identifier Type: -
Identifier Source: org_study_id
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