NCT06075511

A Study of Sleeve Gastrectomy Risks and Benefits

Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	6 minutes walk distance	Subjects walk as far as possible for 6 minutes at a self-selected pace, and the total distance walked will be recorded
BEHAVIORAL	Activity Monitor	Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.
BEHAVIORAL	Continuous Glucose Monitor	Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.
BEHAVIORAL	Blood Pressure Monitoring	Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day
DIAGNOSTIC_TEST	Blood Pressure Monitoring	24-hour ambulatory blood pressure monitoring
DIAGNOSTIC_TEST	Body Composition Scan	Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
DIAGNOSTIC_TEST	Mixed meal testing	Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min
DIAGNOSTIC_TEST	Quality of Life	Subject will complete Quality of Life Questionnaire

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-10-10
• Last updated: 2025-01-30