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

Inclusion Criteria3

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

Exclusion Criteria8

  • 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.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03821636


Related Trials