A Study of Sleeve Gastrectomy Risks and Benefits

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06075511
• Other study ID #: 23-002715
• Status: Enrolling by invitation
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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.
• Continuous Glucose Monitor
Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.
• 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
• Body Composition Scan
Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
• Mixed meal testing
Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min
• Quality of Life
Subject will complete Quality of Life Questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute walk distance (6MWD)	Total distance walked at a self-selected pace reported in meters	Baseline, 12 weeks
Secondary	Change in Short Physical Performance Battery (SPPB) score	Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance.	Baseline, 12 weeks
Secondary	Change in total step count	Total number of steps taken as measured by ActiGraph	Baseline, 12 weeks
Secondary	Change in quality of life	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.	Baseline, 12 weeks
Secondary	Change in glucose metrics	Assessed by continuous glucose metabolism.	Baseline, 12 weeks
Secondary	change in insulin, C peptide and glucose metrics	Assessed by mixed meal testing.	Baseline, 12 weeks
Secondary	Change in blood pressure	Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring	Baseline, 12 weeks