Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Roux-en-Y gastric bypass, Long alimentary limb Roux-en-Y gastric bypass.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 2 in Obese. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
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.
Interventions
- Procedure Standard 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). - Procedure Long 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
Primary outcome measures
- Rate of type 2 diabetes remission [Time frame: at 12 months after surgery]
Secondary outcome measures (12)
- 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 [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 [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 [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. [Time frame: Before surgery and at 12 after surgery]
- Change in glucose homeostasis [Time frame: Before surgery and at 3, 6 and 12 months after surgery]
- Change in HbA1c [Time frame: Before surgery and at 3, 6 and 12 months after surgery]
- Change in fasting glycemia [Time frame: Before surgery and at 3, 6 and 12 months after surgery]
- changes in fasting insulinemia [Time frame: Before surgery and at 3, 6 and 12 months after surgery]
- change in fasting c-peptide [Time frame: Before surgery and at 3, 6 and 12 months after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 4 centers
- Chu Amiens Picardie — Amiens
- Ch Boulogne-Sur-Me — Boulogne-sur-Mer
- Hop Claude Huriez Chu Lille — Lille
- Ch de Valenciennes — Valenciennes
Identifiers
NCT: NCT03821636 · 2017_02 · 2017-A01761-52 · PHRCI-16-090