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

  • End date
    Sep 25, 2029
  • participants needed
  • sponsor
    University Hospital, Lille
Updated on 25 January 2021
body mass index
diabetes mellitus
type 2 diabetes mellitus
hemoglobin a1c
glycosylated hemoglobin
bariatric surgery
gastric bypass
glucagon-like peptide-1


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.


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.

Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), adiposity, Obesity, Obesity, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, Diabetes, type 2 diabetes mellitus, diabetes mellitus (dm), type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Gastric By-Pass, optimized medical management
Clinical Study IdentifierNCT01501201
SponsorUniversity Hospital, Lille
Last Modified on25 January 2021


Yes No Not Sure

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
Affiliation of health care assurance
Psychiatric disorders
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note