Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2025-03-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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
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
Interventions
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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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accepted for sleeve gastrectomy (SG).
* Accepted for kidney transplantation if criteria are met after SG.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Aleksandra Kukla
Principal Investigator
Principal Investigators
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Aleksandra Kukla, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-002715
Identifier Type: -
Identifier Source: org_study_id
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