A Study of Sleeve Gastrectomy Risks and Benefits

NCT06075511 | Withdrawn

• 1 other identifier: 23-002715
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Failure

Keywords

Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance (6MWD)

  Total distance walked at a self-selected pace reported in meters

  Baseline, 12 weeks

Secondary Outcomes (6)

• Change in Short Physical Performance Battery (SPPB) score

  Baseline, 12 weeks

• Change in total step count

  Baseline, 12 weeks

• Change in quality of life

  Baseline, 12 weeks

• Change in glucose metrics

  Baseline, 12 weeks

• change in insulin, C peptide and glucose metrics

  Baseline, 12 weeks

Study Arms (1)

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; Behavioral: Activity Monitor; Behavioral: Continuous Glucose Monitor; Behavioral: Blood Pressure Monitoring; Diagnostic Test: Blood Pressure Monitoring; Diagnostic Test: Body Composition Scan; Diagnostic Test: Mixed meal testing; Diagnostic Test: Quality of Life

Interventions

6 minutes walk distance DIAGNOSTIC_TEST

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

Also known as: 6MWD

Renal Failure Sleeve Gastrectomy

Activity Monitor BEHAVIORAL

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

Renal Failure Sleeve Gastrectomy

Continuous Glucose Monitor BEHAVIORAL

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

Also known as: CGM

Renal Failure Sleeve Gastrectomy

Blood Pressure Monitoring BEHAVIORAL

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

Renal Failure Sleeve Gastrectomy

Body Composition Scan DIAGNOSTIC_TEST

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

Also known as: DEXA Scan

Renal Failure Sleeve Gastrectomy

Mixed meal testing DIAGNOSTIC_TEST

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

Renal Failure Sleeve Gastrectomy

Quality of Life DIAGNOSTIC_TEST

Subject will complete Quality of Life Questionnaire

Also known as: PROMIS Questionnaire

Renal Failure Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Kidney transplant candidates with obesity.
• Accepted for sleeve gastrectomy (SG).
• Accepted for kidney transplantation if criteria are met after SG.

You may not qualify if:

• Not undergoing sleeve gastrectomy.
• Unable to connect through telehealth technology.
• History of medical non-adherence that can affect adherence to the protocol.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples will be collected at baseline and 12 months for future studies s)

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Fitness Trackers; Blood Pressure Monitors; Blood Pressure Monitoring, Ambulatory; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Sphygmomanometers; Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Aleksandra Kukla, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 10, 2023
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share