A Study of Sleeve Gastrectomy Risks and Benefits

NCT ID: NCT06075511

Last Updated: 2025-01-30

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Subjects walk as far as possible for 6 minutes at a self-selected pace, and the total distance walked will be recorded

Activity Monitor

Intervention Type BEHAVIORAL

Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.

Continuous Glucose Monitor

Intervention Type BEHAVIORAL

Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.

Blood Pressure Monitoring

Intervention Type BEHAVIORAL

Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day

Blood Pressure Monitoring

Intervention Type DIAGNOSTIC_TEST

24-hour ambulatory blood pressure monitoring

Body Composition Scan

Intervention Type DIAGNOSTIC_TEST

Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.

Mixed meal testing

Intervention Type DIAGNOSTIC_TEST

Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min

Quality of Life

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Activity Monitor

Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.

Intervention Type BEHAVIORAL

Continuous Glucose Monitor

Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.

Intervention Type BEHAVIORAL

Blood Pressure Monitoring

Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day

Intervention Type BEHAVIORAL

Blood Pressure Monitoring

24-hour ambulatory blood pressure monitoring

Intervention Type DIAGNOSTIC_TEST

Body Composition Scan

Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.

Intervention Type DIAGNOSTIC_TEST

Mixed meal testing

Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min

Intervention Type DIAGNOSTIC_TEST

Quality of Life

Subject will complete Quality of Life Questionnaire

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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6MWD CGM DEXA Scan PROMIS Questionnaire

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Kukla

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandra Kukla, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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23-002715

Identifier Type: -

Identifier Source: org_study_id

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