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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK128640-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Stanford University | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLIMM + Standard RT + Placebo | Placebo Comparator | SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo |
|
| SLIMM + Guided RT + Placebo | Active Comparator | SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo |
|
| SLIMM + Guided RT + Semaglutide | Experimental | SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLIMM | Behavioral | Increase in light walking activity, replacing 1 hour/day of sedentary duration with casual walking duration. Increase in sedentary breaks, from sitting/lying position to standing position, at least once every hour as independent of the total time spent on sedentary activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization | The primary analysis will provide estimates and confidence intervals for the three arms comparisons of changes in sedentary duration from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups that constitute the co-primary comparisons under the study design | Randomization to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Steps per Day at Months 8, 10 and 12 from Randomization | The analysis will provide estimates and confidence intervals for the three arms comparisons of changes in steps per day from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups. | Randomization to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Patient Reported Fatigue at Months 6 and 12 from Randomization | Changes in patient reported fatigue as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| Average Change in Patient Reported Sleep at Months 6 and 12 from Randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amara Sarwal, M.D. | Contact | 801-585-9815 | Amara.Sarwal@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Srinivasan Beddhu, M.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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|
| Standard Resistance Training | Behavioral | Participants will be provided a standard resistance training regimen to follow during the course of the study. Participants will not receive individualized instruction, guidance or modification to the resistance training regimen. |
|
| Guided Resistance Training | Behavioral | Supervised resistance training sessions are individualized for a low-resistance, high-repetition regimen of lower body major muscle groups with established guidelines. Instructions and resistance training bands will be provided for home use. Study participants will record compliance to the resistance training regimen for further guidance and potential modification. |
|
| Placebo | Drug | Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period. |
|
| Semaglutide | Drug | Oral semaglutide 3 mg/day will be administered for the first month of study drug intervention period, if tolerated, the dose will increase to 7 mg/day for the second month and to a maximum dose of 14 mg/day from the third through ninth months of the drug intervention period. |
|
| Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization |
The analysis will provide estimates and confidence intervals for the three arms comparisons of changes in stepping duration from randomization (at 3 months) to the average of changes at months 8, 10 and 12 between the randomized groups. |
| Randomization to 12 Months |
| Average Change in Six-Minute Walk at Months 6 and 12 from Randomization | Changes in six minute walk distance from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| Average Change in Body Fat % at Months 6 and 12 from Randomization | Changes in average body fat percentage as measured by bioimpedance analysis from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
Changes in patient reported sleep as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12 |
| Randomization to 12 Months |
| Average Change in Patient Reported Quality of Life at Months 6 and 12 from Randomization | Changes in patient reported quality of life as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| Average Change in Lower Extremity Performance Battery Composite Score (LEP-CS) at Months 6 and 12 from Randomization | Changes in Lower Extremity Performance Battery Composite Score (LEP-CS) from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| Average Change in Circulating Protein Markers of Inflammation at Months 6 and 12 from Randomization | Changes in circulating protein markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| Average Change in microRNA (miRNA) Markers of Inflammation at Months 6 and 12 from Randomization | Changes in microRNA (miRNA) markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12 | Randomization to 12 Months |
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |