Clinical trial NCT05173714: Sit Less, Interact and Move More (SLIMM) 2 Study
Official title: Sit Less, Interact and Move More (SLIMM) 2 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Diseases
Obesity
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Stanford University
First posted: 2021-12-30
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * 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.


Eligibility criteria: Inclusion Criteria:

* Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Glomerular Filtration Rate (eGFR) 20 to \<60 mL/min/1.73m\^2
* Able to perform resistance training
* Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network), desktop or laptop

Exclusion Criteria:

* Type 1 Diabetes
* History of gastroparesis or paralytic ileus
* At baseline, if sedentary time is 25 min/hr or less, measured by accelerometer
* Potential contraindications to semaglutide such as a history of pancreatitis, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
* Previous bariatric surgery
* Medical condition likely to limit survival to less than 1 year
* Anticipated start of dialysis or kidney transplantation within 6 months
* Any factors judged by the investigator or study team to likely limit adherence to interventions
* Vulnerable populations- pregnant or incarcerated
* Enrolled in interventional trials using drugs or devices
* Not able to undergo informed consent
* Recent hospitalizations or major interventional procedures done within the past 60 days
* Known or suspected hypersensitivity to tegaderm
* Use of any GLP-1 receptor agonist within 30 days prior to screening
* Presently classified as being in New York Heart Association (NYHA) Class IV Heart Failure
* Daytime use of supplemental oxygen (i.e., prescribed a stationary or portable oxygen system)
* Presence of metastatic cancer
* Current use of mobility aid(s)
* Living in the same household of a participant already enrolled in the study

Primary outcomes:
measure: Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization
timeFrame: Randomization to 12 Months
Secondary outcomes:
measure: Average Change in Steps per Day at Months 8, 10 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Six-Minute Walk at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Body Fat % at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
Other outcomes:
measure: Average Change in Patient Reported Fatigue at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Patient Reported Sleep at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Patient Reported Quality of Life at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Lower Extremity Performance Battery Composite Score (LEP-CS) at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in Circulating Protein Markers of Inflammation at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
measure: Average Change in microRNA (miRNA) Markers of Inflammation at Months 6 and 12 from Randomization
timeFrame: Randomization to 12 Months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Srinivasan Beddhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: