A Study of Sleeve Gastrectomy Risks and Benefits
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
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:
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:
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:
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Outcome Measures
Primary Outcome Measures
- Change in 6-minute walk distance (6MWD) [Baseline, 12 weeks]
Total distance walked at a self-selected pace reported in meters
Secondary Outcome Measures
- Change in Short Physical Performance Battery (SPPB) score [Baseline, 12 weeks]
Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance.
- Change in total step count [Baseline, 12 weeks]
Total number of steps taken as measured by ActiGraph
- Change in quality of life [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.
- Change in glucose metrics [Baseline, 12 weeks]
Assessed by continuous glucose metabolism.
- change in insulin, C peptide and glucose metrics [Baseline, 12 weeks]
Assessed by mixed meal testing.
- Change in blood pressure [Baseline, 12 weeks]
Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring
Eligibility Criteria
Criteria
Inclusion Criteria:
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Kidney transplant candidates with obesity.
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Accepted for sleeve gastrectomy (SG).
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Accepted for kidney transplantation if criteria are met after SG.
Exclusion Criteria:
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Not undergoing sleeve gastrectomy.
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Unable to connect through telehealth technology.
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History of medical non-adherence that can affect adherence to the protocol.
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Any other medical condition that in the opinion of the Principal Investigators warrants exclusion for safety reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Minnesota | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Aleksandra Kukla, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-002715