NCT06075511
Withdrawn
Not Applicable
Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT
ConditionsRenal Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Failure
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Primary Endpoint
- Change in 6-minute walk distance (6MWD)
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Aleksandra Kukla
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in 6-minute walk distance (6MWD)
Time Frame: Baseline, 12 weeks
Total distance walked at a self-selected pace reported in meters
Secondary Outcomes
- Change in Short Physical Performance Battery (SPPB) score(Baseline, 12 weeks)
- Change in total step count(Baseline, 12 weeks)
- Change in quality of life(Baseline, 12 weeks)
- Change in glucose metrics(Baseline, 12 weeks)
- Change in blood pressure(Baseline, 12 weeks)
- change in insulin, C peptide and glucose metrics(Baseline, 12 weeks)
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