Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients (DIABSURG)

Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Procedure: Gastric By-Pass; Drug: optimized medical management

Detailed Description

Optimizing the management of type 2 diabetes (T2D) will remain a major public health concern for decades to come. T2DM has already affected 4% of the French population and generates each year over 12 billion euros of expenditure. By combining therapies, oral and/or injectable (insulin or analogues of GLP-1), the current management of T2DM provides two thirds of patients with a satisfactory metabolic control (HbA1c < 7%) and reduced incidence of cardiovascular complications. Its effect on mortality, however, remains more limited, presumably because of the persistence of other cardiovascular risk factors. A recent study has confirmed that French patients with T2DM present an overall mortality risk significantly higher than the general population. In France, this group registered a mortality of 32 deaths per 1000 persons.

Bariatric surgery is now a recognized method for the treatment of severe obesity. It allows for the permanent loss of at least 50% of initial excess weight. In obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly T2D. A recent meta-analysis of retrospective studies available suggests that surgery results in remission of T2DM in over 75% of cases. The only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered T2DM. The gastric by-pass (GBP) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. In patients with T2DM, the GBP restores postprandial insulin secretion independently of weight loss. Despite the significant morbidity of the intervention, long-term results seem broadly supportive of the GBP. In a large case-control study, GBP was associated with a decrease of 90% of deaths related to diabetes. In a controlled study conducted in surgical candidates obese diabetics, the GBP decreased the overall world mortality by 75% after 6 years. Despite these very encouraging data, the GBP is now proposed to only a small proportion (< 1%) of patients likely to benefit from the procedure.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Hospitalier Regional D' Angers
  • Bois-Guillaume, France
    • Hopital de Bois-Guillaume Chu Rouen
  • Boulogne-Billancourt, France
    • Hu Ouest Site Ambroise Pare Aphp -
  • Dommartin-lès-Toul, France
    • Hopital Jeanne D'Arc Chu Nancy
  • Lyon, France, 69008
    • Hopital Lyon Sud - Hcl - Pierre Benite
  • Montpellier, France
    • Hopital Lapeyronie Chu Montpellier
  • Paris, France
    • Hu Pitie Salpetriere Aphp
  • Toulouse, France
    • Hopital Larrey Chu Toulouse
  • Valenciennes, France
    • Ch Valenciennes
  • Nord
    • Lille, Nord, France, 59000
      • University Hospital of Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Type 2 diabetes mellitus with HbA1c > 7.5 %
• Body mass index > 35 and < 50 kg/m2
• Candidate for Gastric By-Pass
• Treatment with GLP1 (glucagon-like peptide) analogue or insulin

Exclusion Criteria:

• Contraindication to bariatric surgery
• Pregnancy
• Affiliation of health care assurance
• Psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric By-Pass; group treated with Gastric By-Pass	Procedure: Gastric By-Pass; Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP); Other Names: RYGBP
Active Comparator: optimized medical management; group receiving an optimized medical management	Drug: optimized medical management; group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall mortality	to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall mortality	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality	7 years
overall mortality	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality	10 years
weight loss	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of weight loss	2 years
glycemic control	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of glycemic control	2 years
quality of life	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of quality of life	2 years
cost, cost-effectiveness and cost utility	The objectives are to compare the results of the GBP to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of cost, cost-effectiveness and cost utility of these two strategies.	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Director: Francois Pattou, Professor, University Hospital of Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2011
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimated): December 29, 2011

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Bariatric Surgery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus
• Other Study ID Numbers: 2010_07/1019; 2010-A01141-38. (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No