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

Obesity Clinical Trial

— OBEDIAB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688974
• Other study ID #: DGS 2004/0123
• Secondary ID: 2004/0412
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 29, 2008
• Last updated: August 17, 2016
• Start date: May 2004
• Est. completion date: September 2012

Study information

• Verified date: August 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2012
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
• Adjustable gastric band
Laparoscopic adjustable gastric band

Locations

Country	Name	City	State
France	Lille University Hospital	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose control	HbA1c and fasting blood glucose	12 months	No
Secondary	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	No
Secondary	Weight loss	Body mass index	60 months	No
Secondary	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	No
Secondary	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	No
Secondary	Diabetes remission	HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug	60 months	No