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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

May 29, 2008
October 22, 2012
May 2004
November 2006   (final data collection date for primary outcome measure)
Diabetic control as assessed by HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluation of glycaemic homeostasis
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 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
  • 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
 
Comparison of 2 Prospective Surgical Techniques in the Treatment of Obesity in Type 2 Diabetes
Comparison of 2 Prospective Surgical Techniques (Gastric Bypass and Adjustable Gastric Banding) in the Treatment of Obesity in Type 2 Diabetes

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
  • Procedure: Gastric Bypass
    L-GB
    Other Name: Laparoscoipic Gastric Bypass
  • Procedure: Adjustable Gastric Banding
    L-AGB
    Other Name: Laparoscopic Adjustable Gastric Banding
  • Experimental: Gastric By-Pass
    Gastric By-Pass - intervention combining gastrointestinal malabsorption and gastric reduction.
    Intervention: Procedure: Gastric Bypass
  • Experimental: Adjustable Gastric banding
    Adjustable Gastric banding
    Intervention: Procedure: Adjustable Gastric Banding
  • No Intervention: Normal subjects
    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
60
September 2012
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00688974
DGS 2004/0123, 2004/0412
Yes
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Francois PATTOU Lille University Hospital
University Hospital, Lille
May 2008

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