A Study of Sleeve Gastrectomy Risks and Benefits

Study Overview
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Brief Summary
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This research study is being conducted to collect information to improve the outcomes of patients who have renal failure and are scheduled to have a sleeve gastrectomy.

Detailed Description
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We will collect information on changes in physical performance, activity, blood pressure and glucose metabolism, body composition, and the quality of life prior to and three months after sleeve gastrectomy.

Official Title
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Prospective Study to Assess Fitness in Patients With Renal Failure Undergoing Sleeve Gastrectomy - PROFIT

Conditions
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Renal Failure

Intervention / Treatment
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* Diagnostic Test: 6 minutes walk distance
* Behavioral: Activity Monitor
* Behavioral: Continuous Glucose Monitor
* Behavioral: Blood Pressure Monitoring
* Diagnostic Test: Blood Pressure Monitoring
* Diagnostic Test: Body Composition Scan
* Diagnostic Test: Mixed meal testing
* Diagnostic Test: Quality of Life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant candidates with obesity. Accepted for sleeve gastrectomy (SG). Accepted for kidney transplantation if criteria are met after SG. Exclusion Criteria: Not undergoing sleeve gastrectomy. Unable to connect through telehealth technology. History of medical non-adherence that can affect adherence to the protocol. Any other medical condition that in the opinion of the Principal Investigators warrants exclusion for safety reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal Failure Sleeve Gastrectomy<br>Subjects that have renal failure and are undergoing a sleeve gastrectomy per standard clinical care will perform a 6-minute walk distance (6MWD) evaluation, activity monitoring, continuous glucose monitor (CGM), blood pressure monitoring, complete mixed meal test, and composition body scan to gather additional information for researchers. | Diagnostic Test: 6 minutes walk distance<br>* Subjects walk as far as possible for 6 minutes at a self-selected pace, and the total distance walked will be recorded<br>* Other names: 6MWD;Behavioral: Activity Monitor<br>* Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.<br>Behavioral: Continuous Glucose Monitor<br>* Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.<br>* Other names: CGM;Behavioral: Blood Pressure Monitoring<br>* Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day<br>Diagnostic Test: Blood Pressure Monitoring<br>* 24-hour ambulatory blood pressure monitoring<br>Diagnostic Test: Body Composition Scan<br>* Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.<br>* Other names: DEXA Scan;Diagnostic Test: Mixed meal testing<br>* Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min<br>Diagnostic Test: Quality of Life<br>* Subject will complete Quality of Life Questionnaire<br>* Other names: PROMIS Questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute walk distance (6MWD) | Total distance walked at a self-selected pace reported in meters | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) score | Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance. | Baseline, 12 weeks | 
| Change in total step count | Total number of steps taken as measured by ActiGraph | Baseline, 12 weeks | 
| Change in quality of life | Assessed by the PROMIS 29 questionnaire to assess seven health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) on an individual scoring scale of 1-5 where 1= not all all and 5= very much. | Baseline, 12 weeks | 
| Change in glucose metrics | Assessed by continuous glucose metabolism. | Baseline, 12 weeks | 
| change in insulin, C peptide and glucose metrics | Assessed by mixed meal testing. | Baseline, 12 weeks | 
| Change in blood pressure | Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve Gastrectomy