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

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.

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 Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2 in Obese
• Intervention / Treatment: Procedure: Standard Roux-en-Y gastric bypass; Procedure: Long alimentary limb Roux-en-Y gastric bypass

• Study Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
  • Boulogne Sur Mer, France, 62321
    • Recruiting
    • Ch Boulogne-Sur-Me
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chu Lille
  • Valenciennes, France
    • Recruiting
    • CH de Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Standard Roux-en-Y	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).
ACTIVE_COMPARATOR: Long alimentary limb Roux-en-Y	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2019
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Bariatric Surgery; Roux-en-Y; Diabetes Mellitus Type 2; gastric bypass
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017_02; 2017-A01761-52 (OTHER: ID-RCB number, ANSM); PHRCI-16-090 (OTHER: PHRC number, DGOS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No