ObesityPhase 4DIABSURGNCT01501201
Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients
A Phase 4 study testing Gastric By-Pass and optimized medical management in people with Obesity and Diabetes, run by University Hospital, Lille at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Gastric By-Pass and optimized medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 10 sitesFrance
- Study dates
- 8 Aug 2011to 27 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to bariatric surgery
- Pregnancy
- Affiliation of health care assurance
- Psychiatric disorders
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Hospitalier Regional D' Angers
Angers
Hopital de Bois-Guillaume Chu Rouen
Bois-Guillaume
Hu Ouest Site Ambroise Pare Aphp -
Boulogne-Billancourt
Hopital Jeanne D'Arc Chu Nancy
Dommartin-lès-Toul
University Hospital of Lille
Lille, Nord, 59000
Hopital Lyon Sud - Hcl - Pierre Benite
Lyon, 69008
Hopital Lapeyronie Chu Montpellier
Montpellier
Hu Pitie Salpetriere Aphp
Paris
Hopital Larrey Chu Toulouse
Toulouse
Ch Valenciennes
Valenciennes
About this study
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
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.
Read the 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.
- Being tested
- Gastric By-Pass, optimized medical management
- Keywords
- Obesity, Diabetes, Bariatric Surgery
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric By-PassProcedure or surgery
Also called RYGBP
Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
optimized medical managementDrug
group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Gastric By-Pass | Experimental | group treated with Gastric By-Pass Receives: Procedure: Gastric By-Pass |
| optimized medical management | Active comparator | group receiving an optimized medical management Receives: Drug: optimized medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study start8 Aug 2011
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Pattou, Professor, Study director, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501201
- Sponsor's protocol ID
- 2010_07/1019
- Other IDs
- 2010-A01141-38.
- Acronym
- DIABSURG
- Status last verified
- May 2026
- First submitted
- 20 Dec 2011
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01501201
- Acronym / sponsor ID
- DIABSURG / 2010_07/1019
- Keywords
- Obesity, Diabetes, Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Aug 2011 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric By-Pass | Experimental | Procedure: Gastric By-Passgroup treated with Gastric By-Pass |
| optimized medical management | Active comparator | Drug: optimized medical managementgroup receiving an optimized medical management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindication to bariatric surgery
- Pregnancy
- Affiliation of health care assurance
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric By-PassAlso: RYGBPBariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP) | Procedure or surgery | Gastric By-Pass |
| optimized medical managementgroup receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes | Drug | optimized medical management |
Primary outcome
overall mortality
Time frame: 5 years
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
6 secondary outcomes
overall mortality
Time frame: 7 years
overall mortality
Time frame: 10 years
weight loss
Time frame: 2 years
glycemic control
Time frame: 2 years
quality of life
Time frame: 2 years
cost, cost-effectiveness and cost utility
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Pattou, Professor study director
University Hospital of Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gastric By-Pass and optimized medical management in people with Obesity and Diabetes, run by University Hospital, Lille at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.