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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. (PRECI-Surg)

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

Tracking Information
First Submitted Date  ICMJE November 26, 2018
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE June 16, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 2 in Obese
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
396
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Grégory BAUD, MD 3.20.44.42.73 ext +33 gregory.baud@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821636
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Grégory BAUD, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP