Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. (PRECI-Surg)

University Hospital, Lille

Status: Enrolling

Conditions: Diabetes Mellitus Type 2 in Obese

Treatments: Procedure: Long alimentary limb Roux-en-Y gastric bypass; Procedure: Standard Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03821636

PHRCI-16-090 (Other Identifier)

2017_02

2017-A01761-52 (Other Identifier)

Details and patient eligibility

About

In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.

Enrollment: 396 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 35 kg/m2
• All patient with type 2 diabetes
• Patients who were candidates for obesity surgery in accordance with French recommendation

Exclusion criteria

• Severe cognitive or mental disorders
• patient who have already undergone obesity surgery
• Severe and non-stabilised eating disorders
• The likely inability of the patient to participate in lifelong medical follow-up
• Alcohol or psychoactive substances dependence
• The absence of identified prior medical management of obesity
• Diseases that are life-threatening in the short and medium term;
• Contraindications to general anaesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Standard Roux-en-Y

Sham Comparator group

Treatment:

Procedure: Standard Roux-en-Y gastric bypass

Long alimentary limb Roux-en-Y

Active Comparator group

Treatment:

Procedure: Long alimentary limb Roux-en-Y gastric bypass