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

University Hospital, Lille396 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

396

Conditions

Diabetes Mellitus Type 2 in Obese

Interventions

Standard Roux-en-Y gastric bypassPROCEDURE

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).

Long alimentary limb Roux-en-Y gastric bypassPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (4)

Chu Amiens Picardie

Amiens, France

RECRUITING

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, France

RECRUITING

Ch de Valenciennes

Valenciennes, France

RECRUITING

Outcomes

Primary Outcomes

Rate of type 2 diabetes remission

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

Time frame: at 12 months after surgery

Secondary Outcomes

Absolute weight loss (aWL in kg)

Time frame: at 1, 3, 6 and 12 months after surgery

Excess Weight Loss percentage (EWL%)

Time frame: at 1, 3, 6 and 12 months after surgery

Excess BMI Loss percentage (EBL%)

Time frame: at 1, 3, 6 and 12 months after surgery

Medical and surgical complication rates

Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia)

Time frame: 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

Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification

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

Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire

The IWQOL questionnaire to be specifically assess the effects of obesity on health-related quality of life. The five identified scales are Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work. The final 20-item IWQOL includes two primary domains: Physical (7 items) and Psychosocial (13 items)

Time frame: Before surgery and at 12 after surgery

Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.

GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.

Time frame: Before surgery and at 12 after surgery

Change in glucose homeostasis

glucose (mg/dl)