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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00688974
First received: May 29, 2008
Last updated: August 17, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Obesity
Type 2 Diabetes
Procedure: Roux-en-Y gastric bypass
Procedure: Adjustable gastric band
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Glucose control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HbA1c and fasting blood glucose


Secondary Outcome Measures:
  • Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test

  • Weight loss [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Body mass index

  • Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test

  • Diabetes remission [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug


Biospecimen Retention:   Samples Without DNA
serum and plasma during meal test (0, 30, 60, 90, 120, 180 min)

Enrollment: 56
Study Start Date: May 2004
Study Completion Date: September 2012
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Healthy controls
Non-obese, non-diabetic adults

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688974

Locations
France
Lille University Hospital
Lille, Nord, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Francois PATTOU Lille University Hospital
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00688974     History of Changes
Other Study ID Numbers: DGS 2004/0123  2004/0412 
Study First Received: May 29, 2008
Last Updated: August 17, 2016
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Lille:
type 2 diabetes
obesity
gastric bypass
adjustable gastric banding
BMI > 35.
obesity for more than 5 years

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 29, 2016