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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01501201
Acronym
DIABSURG
Enrollment
66
Registered
2011-12-29
Start date
2011-08-08
Completion date
2019-09-27
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

Keywords

Obesity, Diabetes, Bariatric Surgery

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.

Interventions

PROCEDUREGastric By-Pass

Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall mortality5 yearsto 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

MeasureTime frameDescription
overall mortality7 yearsThe 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 loss2 yearsThe 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 control2 yearsThe 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 life2 yearsThe 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 utility2 yearsThe 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.

Countries

France

Contacts

STUDY_DIRECTORFrancois Pattou, Professor

University Hospital of Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026