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

May 29, 2008
August 17, 2016
May 2004
November 2006   (final data collection date for primary outcome measure)
Glucose control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
HbA1c and fasting blood glucose
Diabetic control as assessed by HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00688974 on ClinicalTrials.gov Archive Site
  • 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
  • Basal Glycaemia and Insulinemia after a weight loss of 10% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Weight loss and decrease in BMI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Fructosamines [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Index of insulin resistance ( HOMA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Glycaemia and insulinemia after a normalized(standardized) meal after a weight loss of 10% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum and plasma during meal test (0, 30, 60, 90, 120, 180 min)
Non-Probability Sample

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

  • Obesity
  • Type 2 Diabetes
  • Procedure: Roux-en-Y gastric bypass
    Laparoscopic Roux-en-Y gastric bypass
    Other Name: Gastric bypass
  • Procedure: Adjustable gastric band
    Laparoscopic adjustable gastric band
    Other Name: Gastric Banding
  • Roux-en-Y gastric bypass
    Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
    Intervention: Procedure: Roux-en-Y gastric bypass
  • Adjustable gastric banding
    Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
    Intervention: Procedure: Adjustable gastric band
  • Healthy controls
    Non-obese, non-diabetic adults
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2012
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00688974
DGS 2004/0123, 2004/0412
Yes
Not Provided
Not Provided
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Francois PATTOU Lille University Hospital
University Hospital, Lille
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP