Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
Francois Pattou, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01501201
First received: December 20, 2011
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes
Procedure: Gastric By-Pass
Drug: optimized medical management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • overall mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • overall mortality [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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

  • overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

  • weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • cost, cost-effectiveness and cost utility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 490
Study Start Date: February 2011
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastric By-Pass
group treated with Gastric By-Pass
Procedure: Gastric By-Pass
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
Other Name: 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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501201

Contacts
Contact: Francois Pattou, Professor 00 33 3 20 44 42 73 fpattou@iv-lille2.fr

Locations
France
University Hospital of Lille Recruiting
Lille, Nord, France, 59000
Contact: Violeta Raverdy, MD    00 33 3 20 44 59 62    vraverdi@univ-lille2.fr   
Sub-Investigator: Pierre Fontaine, Professor         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Director: Francois Pattou, Professor University Hospital of Lille
  More Information

No publications provided

Responsible Party: Francois Pattou, Professor of Medecine, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01501201     History of Changes
Other Study ID Numbers: 2010_07/1019
Study First Received: December 20, 2011
Last Updated: September 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Obesity
Diabetes
Bariatric Surgery

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014