Comparison of 2 Prospective Surgical Techniques in the Treatment of Obesity in Type 2 Diabetes - Full Text View

Sponsored by:	University Hospital, Lille
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00688974

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 II Phase III

MedlinePlus related topics: Diabetes Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Comparison of 2 Prospective Surgical Techniques (Gastric Bypass and Adjustable Gastric Banding) in the Treatment of Obesity in Type 2 Diabetes

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	50
Study Start Date:	May 2004
Study Completion Date:	January 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gastric Bypass	Procedure: Gastric Bypass L-GB
2: Experimental Adjustable Gastric banding	Procedure: Adjustable Gastric Banding L-AGB

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, Nord
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 ( Aurelie GOZDZIASZEK (contact person) )
Study ID Numbers:	DGS 2004/0123, CP 04/10
Study First Received:	May 29, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00688974
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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009