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

August 17, 2016 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59037
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Candidate for bariatric surgery (Roux-en-Y gastric bypass OR adjustable gastric band) with class 3 obesity (body mass index ≥ 35 kg/m2) and type 2 diabetes (ADA definition)

OR healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • Gastric Banding
Healthy controls
Non-obese, non-diabetic adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose control
Time Frame: 12 months
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
Time Frame: 3 months
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
3 months
Weight loss
Time Frame: 60 months
Body mass index
60 months
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
12 months
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
60 months
Diabetes remission
Time Frame: 60 months
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Francois PATTOU, Lille University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2004/0123
  • 2004/0412 (Other Identifier: sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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