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Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized meal test
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity focused on measuring Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
  • Age > 18 years
  • Patients must be able to adhere to the study visit schedule and protocol requirements
  • Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
  • Patients who are planned for a LRYGB

Exclusion Criteria:

  • Binge-eating or associated eating disorder
  • Active drug or alcohol addiction
  • Pregnancy and when giving breast feeding
  • A medical history of bariatric surgery
  • Patients with a language barrier which can inhibit patients to follow the correct medical advice
  • Any kind of genetic disorder that can inhibit patients to follow the correct medical advice

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    LBPL-RYGB

    S-RYGB

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline incretine levels during a standardized meal test four weeks after surgery.
    Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
    Change from baseline bile acid levels during a standardized meal test four weeks after surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2017
    Last Updated
    December 19, 2017
    Sponsor
    Rijnstate Hospital
    Collaborators
    University College Dublin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03384303
    Brief Title
    Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass
    Official Title
    Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2016 (Actual)
    Study Completion Date
    May 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rijnstate Hospital
    Collaborators
    University College Dublin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obesity is an increasing world wide problem. Moreover, the increase in patients who are considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative approaches such as diets or medication are unsuccessful in the majority of the patients. Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension, dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose levels, their weight is even more difficult to control. Therefore, bariatric procedures are increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there are different variants available. In a recently initiated randomized controlled trial (RCT) from our centre, a comparison between two variants of RYGB was performed. In this RCT our standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB might improve weight loss and reduction after surgery. The exact mechanism of action is still not fully understood. Stomach volume is decreased and satiety levels often increase, probably due to changes in incretin levels. Passage of foods through the gastrointestinal tract are altered after RYGB. A possible explanation might be found in different levels of incretins (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LBPL-RYGB
    Arm Type
    Other
    Arm Title
    S-RYGB
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Standardized meal test
    Intervention Description
    Preoperatively and postoperatively standardized meal test
    Primary Outcome Measure Information:
    Title
    Change from baseline incretine levels during a standardized meal test four weeks after surgery.
    Time Frame
    Preoperatively and four weeks after surgery
    Title
    Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
    Time Frame
    Preoperatively and four weeks after surgery
    Title
    Change from baseline bile acid levels during a standardized meal test four weeks after surgery.
    Time Frame
    Preoperatively and four weeks after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007). Age > 18 years Patients must be able to adhere to the study visit schedule and protocol requirements Patients must be able to give informed consent and the consent must be obtained prior to any study procedures Patients who are planned for a LRYGB Exclusion Criteria: Binge-eating or associated eating disorder Active drug or alcohol addiction Pregnancy and when giving breast feeding A medical history of bariatric surgery Patients with a language barrier which can inhibit patients to follow the correct medical advice Any kind of genetic disorder that can inhibit patients to follow the correct medical advice

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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