A Study of Sleeve Gastrectomy Risks and Benefits

April 22, 2024 updated by: Aleksandra Kukla, Mayo Clinic

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be identified through the clinical setting that are diagnosed renal failure and scheduled for sleeve gastrectomy per standard of clinical care.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Failure Sleeve Gastrectomy
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.
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
Other Names:
  • 6MWD
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.
Other Names:
  • CGM
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.
Other Names:
  • DEXA Scan
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
Other Names:
  • PROMIS Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute walk distance (6MWD)
Time Frame: Baseline, 12 weeks
Total distance walked at a self-selected pace reported in meters
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short Physical Performance Battery (SPPB) score
Time Frame: Baseline, 12 weeks
Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance.
Baseline, 12 weeks
Change in total step count
Time Frame: Baseline, 12 weeks
Total number of steps taken as measured by ActiGraph
Baseline, 12 weeks
Change in quality of life
Time Frame: Baseline, 12 weeks
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
Change in glucose metrics
Time Frame: Baseline, 12 weeks
Assessed by continuous glucose metabolism.
Baseline, 12 weeks
change in insulin, C peptide and glucose metrics
Time Frame: Baseline, 12 weeks
Assessed by mixed meal testing.
Baseline, 12 weeks
Change in blood pressure
Time Frame: Baseline, 12 weeks
Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Aleksandra Kukla, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-002715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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