NCT06075511|Withdrawn
Study Stopped
Funding
A Study of Sleeve Gastrectomy Risks and Benefits
Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT
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Funding
Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2023
Actual (reported)October 10, 2023
Actual (reported)March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in 6-minute walk distance (6MWD)
Total distance walked at a self-selected pace reported in meters
Baseline, 12 weeks
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 insulin, C peptide and glucose metrics
Baseline, 12 weeks
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.
Subjects walk as far as possible for 6 minutes at a self-selected pace, and the total distance walked will be recorded
Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.
Subjects will be identified through the clinical setting that are diagnosed renal failure and scheduled for sleeve gastrectomy per standard of clinical care.
Kukla A, Kudva YC, Navratil P, Sahi SS, Benzo RP, Fipps DC, Erickson AE, Majorowicz RR, Clark MM, Schinstock CA, Shah P, Shah M, Diwan TS. Management of Patients With Kidney Disease Undergoing Bariatric Surgery: A Multidisciplinary Approach. Mayo Clin Proc. 2024 Mar;99(3):445-458. doi: 10.1016/j.mayocp.2023.11.008.
plasma samples will be collected at baseline and 12 months for future studies s)
Aleksandra Kukla, MD
Mayo Clinic
0 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2023
First Posted
October 10, 2023
Study Start
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Music Intervention for Dialysis Patients
Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.
Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day
24-hour ambulatory blood pressure monitoring
Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min
Subject will complete Quality of Life Questionnaire
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 30, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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