Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 in Obese Procedure: Standard Roux-en-Y gastric bypass Procedure: Long alimentary limb Roux-en-Y gastric bypass Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Absolute weight loss (aWL in kg) [ Time Frame: at 1, 3, 6 and 12 months after surgery ]
  2. Excess Weight Loss percentage (EWL%) [ Time Frame: at 1, 3, 6 and 12 months after surgery ]
  3. Excess BMI Loss percentage (EBL%) [ Time Frame: at 1, 3, 6 and 12 months after surgery ]
  4. 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)

  5. 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

  6. 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)


  7. 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.

  8. Change in glucose homeostasis [ Time Frame: Before surgery and at 3, 6 and 12 months after surgery ]
    glucose (mg/dl)

  9. 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

  10. 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)

  11. changes in fasting insulinemia [ Time Frame: Before surgery and at 3, 6 and 12 months after surgery ]
    Changes in fasting insulinemia in microunits/mL

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821636


Contacts
Layout table for location contacts
Contact: Grégory BAUD, MD 3.20.44.42.73 ext +33 gregory.baud@chru-lille.fr

Locations
Layout table for location information
France
Chu Amiens Picardie Recruiting
Amiens, France
Ch Boulogne-Sur-Me Recruiting
Boulogne Sur Mer, France, 62321
Contact    0321993333      
Hop Claude Huriez Chu Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Ch de Valenciennes Recruiting
Valenciennes, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Layout table for investigator information
Principal Investigator: Grégory BAUD, MD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03821636    
Other Study ID Numbers: 2017_02
2017-A01761-52 ( Other Identifier: ID-RCB number, ANSM )
PHRCI-16-090 ( Other Identifier: PHRC number, DGOS )
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Obesity
Diabetes Mellitus Type 2
Bariatric Surgery
Roux-en-Y
gastric bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases