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NCT Number: NCT00688974

Longitudinal Cohort Study Comparing 2 Surgical Techniques 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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, Nord, 59037, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roux-en-Y gastric bypass

Procedure

Laparoscopic Roux-en-Y gastric bypass

Other names: Gastric bypass

Adjustable gastric band

Procedure

Laparoscopic adjustable gastric band

Other names: Gastric Banding

Primary outcomes

  1. Glucose control

    Time frame: 12 months

    HbA1c and fasting blood glucose

Secondary outcomes

  1. Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss

    Time frame: 3 months

    Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test

  2. Weight loss

    Time frame: 60 months

    Body mass index

  3. Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal

    Time frame: 12 months

    Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test

  4. Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal

    Time frame: 60 months

    Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test

  5. Diabetes remission

    Time frame: 60 months

    HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: OBEDIAB

Important dates

Study start
2004
Primary completion
2006
Study completion
2012
First posted
Jun 3, 2008
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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