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Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation (SG-4MOST)

Primary Purpose

Liver Transplantation, Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleeve gastrectomy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation

Eligibility Criteria

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

Inclusion Criteria:

  • actively listed for liver transplantation at University Health Network
  • BMI at screening of a) >40; or b) BMI >35 and 1 obesity-related complication [diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmHg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)] OR a diagnosis of Non Alcoholic Fatty Liver Disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or Non Alcoholic Steatohepatitis
  • upper endoscopy showing no contraindications to a sleeve gastrectomy procedure

Exclusion Criteria:

  • • Listed for re-transplantation, or transplantation of another organ (eg. kidney).

    • Previous bariatric surgery.
    • Contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or Barrett's Esophagus
    • MELD (Model End-Stage Liver Disease) score > 35 at the time of transplantation
    • Presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures
    • Patients with a BMI <32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening)
    • Presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the SG procedure (eg. significant sarcopenia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Surgical Intervention

    No Surgical Intervention

    Arm Description

    Open Sleeve gastrectomy procedure will be performed immediately following liver transplantation (as a single surgery) or within 2 weeks of transplantation (as a second open surgery)

    Liver transplantation will proceed as per routine practice

    Outcomes

    Primary Outcome Measures

    morbid obesity
    rate of morbid obesity defined as BMI greater than or equal to 35

    Secondary Outcome Measures

    mortality
    patient mortality
    surgical morbidity
    rate of surgical morbidity
    surgical morbidity
    rate of surgical morbidity
    mortality
    patient mortality
    change in weight
    weight loss or gain as percentage of estimated "dry" weight at transplantation
    surgical complications
    rate of surgical complications
    sleep apnea
    percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
    hypertension
    percentage of participants in each group requiring treatment of hypertension
    diabetes
    percentage of participants in each group requiring medical treatment of diabetes
    hyperlipidemia
    percentage of participants in each group requiring medical treatment of elevated lipids

    Full Information

    First Posted
    June 4, 2018
    Last Updated
    May 19, 2023
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03617744
    Brief Title
    Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation
    Acronym
    SG-4MOST
    Official Title
    Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation: A Randomized Controlled Trial Comparing Sleeve Gastrectomy Following Liver Transplantation to No Surgical Intervention in Patients With Morbid Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto

    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
    Complications associated with excess weight (hypertension, coronary artery disease and diabetes) have become major causes of morbidity and mortality after liver transplantation (LT). To ensure excellent long-term outcomes with LT it is critically important to understand the best strategies to minimize obesity and its associated complications in our patients. Weight loss can be achieved through dieting and exercise, but most patients are unable to maintain the weight loss. In the general population, bariatric surgery is much more effective than medical treatment for permanent weight loss and prevention or reduction of obesity-associated complications. The purpose of this study is to determine the safety and effectiveness of performing sleeve gastrectomy (SG) procedure in the early post-LT period in obese patients. The patient population for this study will be anyone listed for liver transplantation at Toronto General Hospital (University Health Network, Toronto, ON, Canada) and meeting the current standard criteria for bariatric surgery (BMI>40, or BMI>35 with at least 1 obesity-related complication).This study will randomly assign eligible participants to one of two groups (1:1). Patients in group 1 will receive standard lifestyle/diet counselling while patients in group 2 will undergo SG-specific counselling prior to transplant and the SG procedure within 2 weeks of LT (if safe to do so). All participants will be followed for 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Transplantation, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1 randomization to group a or group b
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgical Intervention
    Arm Type
    Experimental
    Arm Description
    Open Sleeve gastrectomy procedure will be performed immediately following liver transplantation (as a single surgery) or within 2 weeks of transplantation (as a second open surgery)
    Arm Title
    No Surgical Intervention
    Arm Type
    No Intervention
    Arm Description
    Liver transplantation will proceed as per routine practice
    Intervention Type
    Procedure
    Intervention Name(s)
    Sleeve gastrectomy
    Intervention Description
    Open sleeve gastrectomy
    Primary Outcome Measure Information:
    Title
    morbid obesity
    Description
    rate of morbid obesity defined as BMI greater than or equal to 35
    Time Frame
    12 months post-liver transplant
    Secondary Outcome Measure Information:
    Title
    mortality
    Description
    patient mortality
    Time Frame
    12 months post-transplant
    Title
    surgical morbidity
    Description
    rate of surgical morbidity
    Time Frame
    12 months post-transplant
    Title
    surgical morbidity
    Description
    rate of surgical morbidity
    Time Frame
    3 months post-transplant
    Title
    mortality
    Description
    patient mortality
    Time Frame
    3 months post-transplant
    Title
    change in weight
    Description
    weight loss or gain as percentage of estimated "dry" weight at transplantation
    Time Frame
    12 months
    Title
    surgical complications
    Description
    rate of surgical complications
    Time Frame
    12 months
    Title
    sleep apnea
    Description
    percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
    Time Frame
    12 months post-transplantation
    Title
    hypertension
    Description
    percentage of participants in each group requiring treatment of hypertension
    Time Frame
    12 months post-transplantation
    Title
    diabetes
    Description
    percentage of participants in each group requiring medical treatment of diabetes
    Time Frame
    12 months post-transplantation
    Title
    hyperlipidemia
    Description
    percentage of participants in each group requiring medical treatment of elevated lipids
    Time Frame
    12 months post-transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: actively listed for liver transplantation at University Health Network BMI at screening of a) >40; or b) BMI >35 and 1 obesity-related complication [diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmHg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)] OR a diagnosis of Non Alcoholic Fatty Liver Disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or Non Alcoholic Steatohepatitis upper endoscopy showing no contraindications to a sleeve gastrectomy procedure Exclusion Criteria: • Listed for re-transplantation, or transplantation of another organ (eg. kidney). Previous bariatric surgery. Contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or Barrett's Esophagus MELD (Model End-Stage Liver Disease) score > 35 at the time of transplantation Presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures Patients with a BMI <32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening) Presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the SG procedure (eg. significant sarcopenia)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Erin Winter, BSc
    Phone
    416-340-4800
    Ext
    6093
    Email
    erin.winter@uhn.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David R Grant, M.D.
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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