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Funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk distance (6MWD) | Total distance walked at a self-selected pace reported in meters | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) score | Measure of physical performance through balance, strength, and gait measurements. Total score ranges for 0 = worst performance and 12 = best performance. | Baseline, 12 weeks |
| Change in total step count |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be identified through the clinical setting that are diagnosed renal failure and scheduled for sleeve gastrectomy per standard of clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Kukla, MD | Mayo Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38432750 | Derived | Kukla A, Kudva YC, Navratil P, Sahi SS, Benzo RP, Fipps DC, Erickson AE, Majorowicz RR, Clark MM, Schinstock CA, Shah P, Shah M, Diwan TS. Management of Patients With Kidney Disease Undergoing Bariatric Surgery: A Multidisciplinary Approach. Mayo Clin Proc. 2024 Mar;99(3):445-458. doi: 10.1016/j.mayocp.2023.11.008. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| D015924 | Blood Pressure Monitors |
| D018660 | Blood Pressure Monitoring, Ambulatory |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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plasma samples will be collected at baseline and 12 months for future studies s)
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| Activity Monitor | Behavioral | Subjects will wear an Actigraph on their wrist like a watch for up to 10 days at home to monitor activity. |
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| Continuous Glucose Monitor | Behavioral | Subjects will collect glucose values in the fluid under their skin for up to 10 days at home. |
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| Blood Pressure Monitoring | Behavioral | Subjects will monitor their blood pressure at home for 10 consecutive days 3 times a day |
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| Blood Pressure Monitoring | Diagnostic Test | 24-hour ambulatory blood pressure monitoring |
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| Body Composition Scan | Diagnostic Test | Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat. |
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| Mixed meal testing | Diagnostic Test | Subjects will consume 6 ml/kg body weight of Boost, up to maximum of 360 ml, within 5 min |
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| Quality of Life | Diagnostic Test | Subject will complete Quality of Life Questionnaire |
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Total number of steps taken as measured by ActiGraph |
| Baseline, 12 weeks |
| Change in quality of life | 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. | Baseline, 12 weeks |
| Change in glucose metrics | Assessed by continuous glucose metabolism. | Baseline, 12 weeks |
| change in insulin, C peptide and glucose metrics | Assessed by mixed meal testing. | Baseline, 12 weeks |
| Change in blood pressure | Assessed by ambulatory blood pressure monitoring and home blood pressure monitoring | Baseline, 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D019722 | Sphygmomanometers |
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |