NCT Number: NCT05173714
* Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death. * In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained. * Therefore, the researchers are currently conducting a follow-up study named Sit Less, Interact and Move More (SLIMM) 2. * This NIH funded study is conducted at the University of Utah and Stanford University. * The purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (FDA approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the SLIMM Intervention and reduce sedentary behavior.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Phase 2
Stanford University, Stanford, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.
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.
Time frame: Randomization to 12 Months
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
Time frame: Randomization to 12 Months
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.
Time frame: Randomization to 12 Months
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.
Time frame: Randomization to 12 Months
Changes in six minute walk distance from randomization (at 3 months) to the average of changes at months 6 and 12
Time frame: Randomization to 12 Months
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
Time frame: Randomization to 12 Months
Changes in patient reported fatigue as measured by questionaires from randomization (at 3 months) to the average of changes at months 6 and 12
Time frame: 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
Time frame: Randomization to 12 Months
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
Time frame: Randomization to 12 Months
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
Time frame: Randomization to 12 Months
Changes in circulating protein markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12
Time frame: Randomization to 12 Months
Changes in microRNA (miRNA) markers of inflammation from randomization (at 3 months) to the average of changes at months 6 and 12
Contact information is provided by the study sponsor or research team.
Srinvasan Beddhu
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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