Clinical trial NCT03821636: Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 2 in Obese
Keywords: Obesity
Diabetes Mellitus Type 2
Bariatric Surgery
Roux-en-Y
gastric bypass
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2019-01-30
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of type 2 diabetes remission
timeFrame: at 12 months after surgery
Secondary outcomes:
measure: Absolute weight loss (aWL in kg)
timeFrame: at 1, 3, 6 and 12 months after surgery
measure: Excess Weight Loss percentage (EWL%)
timeFrame: at 1, 3, 6 and 12 months after surgery
measure: Excess BMI Loss percentage (EBL%)
timeFrame: at 1, 3, 6 and 12 months after surgery
measure: Medical and surgical complication rates
timeFrame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
measure: Type and severity of early and late complications for each procedure
timeFrame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
measure: Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire
timeFrame: Before surgery and at 12 after surgery
measure: Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.
timeFrame: Before surgery and at 12 after surgery
measure: Change in glucose homeostasis
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: Change in HbA1c
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: Change in fasting glycemia
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: changes in fasting insulinemia
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: change in fasting c-peptide
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: Number of antidiabetic treatments
timeFrame: Before surgery and at 3, 6 and 12 months after surgery
measure: Changes in blood lipids profile
timeFrame: Before surgery and at 1, 3, 6 and 12 months after surgery
measure: change in vitamins status assessment
timeFrame: Before surgery and at 1, 3, 6 and 12 months after surgery
measure: change in prealbumin levels
timeFrame: Before surgery and at 1, 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne-Sur-Me
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Valenciennes
country: France
facility: Ch de Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Grégory BAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: