Clinical trial NCT01501201: Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Diabetes
Keywords: Obesity
Diabetes
Bariatric Surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: overall mortality
timeFrame: 5 years
Secondary outcomes:
measure: overall mortality
timeFrame: 7 years
measure: overall mortality
timeFrame: 10 years
measure: weight loss
timeFrame: 2 years
measure: glycemic control
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
measure: cost, cost-effectiveness and cost utility
timeFrame: 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital of Lille
state: Nord
city: Angers
country: France
facility: Centre Hospitalier Regional D' Angers
city: Bois-Guillaume
country: France
facility: Hopital de Bois-Guillaume Chu Rouen
city: Boulogne-Billancourt
country: France
facility: Hu Ouest Site Ambroise Pare Aphp -
city: Dommartin Les Toul
country: France
facility: Hopital Jeanne D'Arc Chu Nancy
city: Lyon
country: France
facility: Hopital Lyon Sud - Hcl - Pierre Benite
city: Montpellier
country: France
facility: Hopital Lapeyronie Chu Montpellier
city: Paris
country: France
facility: Hu Pitie Salpetriere Aphp
city: Toulouse
country: France
facility: Hopital Larrey Chu Toulouse
city: Valenciennes
country: France
facility: Ch Valenciennes
Study officials:
affiliation: University Hospital of Lille
name: Francois Pattou, Professor
role: STUDY_DIRECTOR
References: