Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03617744
• Other study ID #: 17-6286
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Erin Winter, BSc
• Phone: 416-340-4800
• Email: erin.winter[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Liver Transplantation
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Sleeve gastrectomy
Open sleeve gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbid obesity	rate of morbid obesity defined as BMI greater than or equal to 35	12 months post-liver transplant
Secondary	mortality	patient mortality	12 months post-transplant
Secondary	surgical morbidity	rate of surgical morbidity	12 months post-transplant
Secondary	surgical morbidity	rate of surgical morbidity	3 months post-transplant
Secondary	mortality	patient mortality	3 months post-transplant
Secondary	change in weight	weight loss or gain as percentage of estimated "dry" weight at transplantation	12 months
Secondary	surgical complications	rate of surgical complications	12 months
Secondary	sleep apnea	percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea	12 months post-transplantation
Secondary	hypertension	percentage of participants in each group requiring treatment of hypertension	12 months post-transplantation
Secondary	diabetes	percentage of participants in each group requiring medical treatment of diabetes	12 months post-transplantation
Secondary	hyperlipidemia	percentage of participants in each group requiring medical treatment of elevated lipids	12 months post-transplantation