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Comparison of 2 Prospective Surgical Techniques in the Treatment of Obesity in 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: October 22, 2012
Last verified: May 2008
History of Changes
  Purpose

The bariatric surgery provides a better glycemic control type 2 diabetes. The technique of "Gastric Bypass" is more effective than the Adjustable Gastric Banding on weight loss.

This study is a prospective objective comparison of the effectiveness of the "Gastric Bypass" (GBP) and Adjustable Gastric Banding on glycemic control in type 2 diabetes.

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: Gastric Bypass
Procedure: Adjustable Gastric Banding
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of 2 Prospective Surgical Techniques (Gastric Bypass and Adjustable Gastric Banding) in the Treatment of Obesity in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Diabetic control as assessed by HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of glycaemic homeostasis


Secondary Outcome Measures:
  • Glycaemia, Insulinemia, Incretins during a normalized(standardized) meal at 10% of weight loss [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Area Under the Curve (AUC)of Glycaemia, Insulinemia, Incretins during a normalized(standardized) meal

  • BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Weight loss

  • Index of insulin resistance ( HOMA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Insulin secretion

  • Glycaemia, Insulinemia and Incretins during a normalized(standardized) meal [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Area Under the Curve (AUC)of Glycaemia, Insulinemia, Incretins during a normalized(standardized) meal

  • Glycaemia, insulinemia and incretins during a normalized(standardized) meal [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Area Under the Curve (AUC)of Glycaemia, Insulinemia, Incretins during a normalized(standardized) meal

  • BMI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Weight loss


Enrollment: 60
Study Start Date: May 2004
Study Completion Date: September 2012
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastric By-Pass
Gastric By-Pass - intervention combining gastrointestinal malabsorption and gastric reduction.
 Procedure: Gastric Bypass
L-GB
Other Name: Laparoscoipic Gastric Bypass
Experimental: Adjustable Gastric banding
Adjustable Gastric banding
 Procedure: Adjustable Gastric Banding
L-AGB
Other Name: Laparoscopic Adjustable Gastric Banding
No Intervention: Normal subjects
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, gastric banding procedure (ring gastric) is the simplest and by far the most widespread in France.

"Gastric Bypass" or gastro-bypass jejunal 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 the prospective comparison of the efficiency of "Gastric Bypass" and gastric ring on glycemic control in Type 2 diabetes. Although some studies have compared the ring and GBP, none have compared their effectiveness on the blood sugar in patients with diabetes. It is generally recognized that the effectiveness of GBP on diabetes is independent of the weight loss.

By demonstrating the superiority of gastric bypass, the study will expand the indications of gastric by-pass in the treatment of type 2 diabetes among the obese subject.The hormonal changes observed in the gastric bypass have never been studied by comparing them with those observed in the ring procedure, and independent of changes in weight loss. Surgery for obesity offers a unique model and particularly relevant to clinical study of the pathophysiology of type 2 diabetes.

Main objective:

  • To compare the effectiveness of gastric bypass and gastric ring on control of blood sugar in obese patients with type 2 diabetes.

Secondary Objectives:

  • Show that the best glycemic control achieved with the technique of gastric bypass is done independently of weight loss.
  • Show the responsibility of hormonal changes on improving the blood sugar.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years
  • BMI > 35
  • Type 2 diabetes
  • Obesity for more than 5 years

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
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

No publications provided

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: October 22, 2012
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 June 18, 2013