RecruitingNot ApplicableNCT03821636

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

Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled Trial.


Sponsor

University Hospital, Lille

Enrollment

396 participants

Start Date

Jun 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different surgical techniques for gastric bypass surgery (a type of weight-loss surgery) to see which one leads to better diabetes remission in patients with severe obesity and type 2 diabetes. **You may be eligible if...** - You have a BMI of 35 kg/m² or higher - You have type 2 diabetes - You have been recommended for obesity surgery based on French national guidelines **You may NOT be eligible if...** - You have severe cognitive problems or serious mental health disorders - You have already had weight-loss surgery before - You have severe, uncontrolled eating disorders - You are unlikely to be able to attend lifelong medical follow-up appointments - You have an alcohol or substance dependence problem - You have no documented prior medical management of your obesity - You have a life-threatening illness in the short or medium term - You have a medical condition preventing you from safely receiving general anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard Roux-en-Y gastric bypass

Standard Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 25 % of total length of the intestine (150 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 65 % of total length of the intestine (400 cm).

PROCEDURELong alimentary limb Roux-en-Y gastric bypass

Long alimentary limb Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 45 % of total length of the intestine (280 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 45 % of total length of the intestine (280 cm


Locations(4)

Chu Amiens Picardie

Amiens, France

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, France

Hop Claude Huriez Chu Lille

Lille, France

Ch de Valenciennes

Valenciennes, France

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NCT03821636


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