Renal Failure
Conditions
Keywords
Sleeve Gastrectomy
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.
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.
Interventions
DIAGNOSTIC_TEST6 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
BEHAVIORALActivity Monitor
Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity.
BEHAVIORALContinuous Glucose Monitor
Subjects will collect glucose values in the fluid under their skin for up to 10 days at home.
BEHAVIORALBlood Pressure Monitoring
Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day
DIAGNOSTIC_TESTBody Composition Scan
Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
DIAGNOSTIC_TESTMixed meal testing
Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min
DIAGNOSTIC_TESTQuality of Life
Subject will complete Quality of Life Questionnaire
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute walk distance (6MWD) | Baseline, 12 weeks | Total distance walked at a self-selected pace reported in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Change in glucose metrics | Baseline, 12 weeks | Assessed by continuous glucose metabolism. |
Outcome results
None listed