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

Obesity Clinical Trial

— DIABSURG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01501201
• Other study ID #: 2010_07/1019
• Secondary ID: 2010-A01141-38.
• Status: Recruiting
• Phase: Phase 4
• Start date: August 8, 2011
• Est. completion date: September 2029

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Francois Pattou, Professor
• Phone: 00 33 3 20 44 42 73
• Email: fpattou[@]iv-lille2.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Procedure:
• Gastric By-Pass
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)

Drug:
• optimized medical management
group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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