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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus Type 2 in Obese

Intervention / Treatment
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* Procedure: Standard Roux-en-Y gastric bypass
* Procedure: Long alimentary limb Roux-en-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard Roux-en-Y<br> | Procedure: Standard Roux-en-Y gastric bypass<br>* 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).<br>|
| Active Comparator: Long alimentary limb Roux-en-Y<br> | Procedure: Long alimentary limb Roux-en-Y gastric bypass<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia) | 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 | 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) | 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. | Before surgery and at 12 after surgery | 
| Change in glucose homeostasis | glucose (mg/dl) | Before surgery and at 3, 6 and 12 months after surgery | 
| Change in HbA1c | Changes in HbA1c(%) were assessed before and after surgery | Before surgery and at 3, 6 and 12 months after surgery | 
| Change in fasting glycemia | Changes in fasting blood glucose levels (mmol/L) | Before surgery and at 3, 6 and 12 months after surgery | 
| changes in fasting insulinemia | Changes in fasting insulinemia in microunits/mL | Before surgery and at 3, 6 and 12 months after surgery | 
| change in fasting c-peptide | Changes in C-peptide(ng/ml) were assessed before and after the intervention. | Before surgery and at 3, 6 and 12 months after surgery | 
| Number of antidiabetic treatments | Metabolic profile of glucose homeostasis assessment according to antidiabetic treatments, HbA1c level, fasting glycemia, fasting insulinemia fasting c-peptide | Before surgery and at 3, 6 and 12 months after surgery | 
| Changes in blood lipids profile | Changes in blood lipids profile (LDL, HDL and triglyceride concentrations) according to anitilipidemic treatments | Before surgery and at 1, 3, 6 and 12 months after surgery | 
| change in vitamins status assessment | vitamines profil (vitamin B1, B9, B12, and D concentration) before and 12 and 24 months after surgery | Before surgery and at 1, 3, 6 and 12 months after surgery | 
| change in prealbumin levels | Lower levels of prealbumin are associated with malnutrition. | Before surgery and at 1, 3, 6 and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes Mellitus Type 2, Bariatric Surgery, Roux-en-Y, gastric bypass