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Clinical Trials/NCT06075511
NCT06075511
Withdrawn
Not Applicable

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

Mayo Clinic0 sites30 target enrollmentMarch 2025
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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
March 2025
End Date
March 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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