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

NCT03821636 | Recruiting DMC

• 3 other identifiers: 2017_022017-A01761-52PHRCI-16-090
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Obesity; Diabetes Mellitus Type 2; Bariatric Surgery; Roux-en-Y; gastric bypass

Outcome Measures

Primary Outcomes (1)

• Rate of type 2 diabetes remission

  HbA1c \< 6.5% AND fasting blood glucose \< 7.0 mmol/L in absence of antidiabetic drug

  at 12 months after surgery

Secondary Outcomes (16)

• Absolute weight loss (aWL in kg)

  at 1, 3, 6 and 12 months after surgery

• Excess Weight Loss percentage (EWL%)

  at 1, 3, 6 and 12 months after surgery

• Excess BMI Loss percentage (EBL%)

  at 1, 3, 6 and 12 months after surgery

• Medical and surgical complication rates

  During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]

• Type and severity of early and late complications for each procedure

  During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]

Study Arms (2)

Standard Roux-en-Y

SHAM COMPARATOR

Procedure: Standard Roux-en-Y gastric bypass

Long alimentary limb Roux-en-Y

ACTIVE COMPARATOR

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

Interventions

Standard Roux-en-Y gastric bypass PROCEDURE

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).

Standard Roux-en-Y

Long alimentary limb Roux-en-Y gastric bypass PROCEDURE

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

Long alimentary limb Roux-en-Y

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (4)

Chu Amiens Picardie

Amiens, France

RECRUITING

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, 62321, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

Ch de Valenciennes

Valenciennes, France

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Grégory BAUD, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégory BAUD, MD

CONTACT

3.20.44.42.73; gregory.baud@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: January 30, 2019
• Study Start: June 16, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (4)