About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
BMI ≥ 35 kg/m2
All patient with type 2 diabetes
Patients who were candidates for obesity surgery in accordance with French recommendation
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Standard Roux-en-Y gastric bypass
Procedure/SurgeryStandard 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 bypass
Procedure/SurgeryLong 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
Treatment groups
Trial 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
Secondary outcomes
Absolute weight loss (aWL in kg)
Excess Weight Loss percentage (EWL%)
Excess BMI Loss percentage (EBL%)
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)
Sponsors and contacts
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University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator