A Study of Sleeve Gastrectomy Risks and Benefits

Withdrawn

• Conditions: Renal Failure
• Interventions: Diagnostic Test: 6 minutes walk distance; Behavioral: Activity Monitor; Behavioral: Continuous Glucose Monitor; Diagnostic Test: Blood Pressure Monitoring; Diagnostic Test: Body Composition Scan; Diagnostic Test: Mixed meal testing; Diagnostic Test: Quality of Life

• Registration Number: NCT06075511
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Study Start: 2025-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal Failure Sleeve Gastrectomy	Activity Monitor	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.
Renal Failure Sleeve Gastrectomy	6 minutes walk distance	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.
Renal Failure Sleeve Gastrectomy	Mixed meal testing	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.
Renal Failure Sleeve Gastrectomy	Continuous Glucose Monitor	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.
Renal Failure Sleeve Gastrectomy	Body Composition Scan	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.
Renal Failure Sleeve Gastrectomy	Quality of Life	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.
Renal Failure Sleeve Gastrectomy	Blood Pressure Monitoring	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.

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk distance (6MWD)	Baseline, 12 weeks	Total distance walked at a self-selected pace reported in meters

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB) score	Baseline, 12 weeks	Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance.
Change in total step count	Baseline, 12 weeks	Total number of steps taken as measured by ActiGraph
Change in quality of life	Baseline, 12 weeks	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.
Change in glucose metrics	Baseline, 12 weeks	Assessed by continuous glucose metabolism.
Change in blood pressure	Baseline, 12 weeks	Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring
change in insulin, C peptide and glucose metrics	Baseline, 12 weeks	Assessed by mixed meal testing.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States