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)

• ClinicalTrials.gov Identifier: NCT03821636
• Recruitment Status: Recruiting
• First Posted: January 30, 2019
• Last Update Posted: September 14, 2020
• Sponsor: University Hospital, Lille
• Collaborator: Ministry of Health, France
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: November 26, 2018
• First Posted Date: January 30, 2019
• Last Update Posted Date: September 14, 2020
• Actual Study Start Date: June 16, 2019
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2019)

Rate of type 2 diabetes remission [ Time Frame: at 12 months after surgery ]

HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 28, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetes Mellitus Type 2 in Obese

Intervention

• 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

Study Arms

• Sham Comparator: Standard Roux-en-Y
  Intervention: Procedure: Standard Roux-en-Y gastric bypass
• Active Comparator: Long alimentary limb Roux-en-Y
  Intervention: Procedure: Long alimentary limb Roux-en-Y gastric bypass

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 28, 2019): 396
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Grégory BAUD, MD; 3.20.44.42.73 ext +33; gregory.baud@chru-lille.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03821636
• Other Study ID Numbers: 2017_02; 2017-A01761-52 ( Other Identifier: ID-RCB number, ANSM ); PHRCI-16-090 ( Other Identifier: PHRC number, DGOS )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Lille
• Study Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France

Investigators

• Principal Investigator: Grégory BAUD, MD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: September 2020