NCT03821636

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Type 2 in Obese

Interventions

Type	Name	Description
PROCEDURE	Standard 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).
PROCEDURE	Long 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

Timeline

• Start date: 2019-06-16
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-01-30
• Last updated: 2025-12-23

Locations

4 sites across 1 country: France