Sit Less, Interact and Move More (SLIMM) 2 Study

NCT05173714 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 1384941R01DK128640-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Diseases; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Average Change in Steps per Day at Months 8, 10 and 12 from Randomization

  Randomization to 12 Months

• Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization

  Randomization to 12 Months

• Average Change in Six-Minute Walk at Months 6 and 12 from Randomization

  Randomization to 12 Months

• Average Change in Body Fat % at Months 6 and 12 from Randomization

  Randomization to 12 Months

Other Outcomes (6)

• Average Change in Patient Reported Fatigue at Months 6 and 12 from Randomization

  Randomization to 12 Months

• Average Change in Patient Reported Sleep at Months 6 and 12 from Randomization

  Randomization to 12 Months

• Average Change in Patient Reported Quality of Life at Months 6 and 12 from Randomization

  Randomization to 12 Months

Study Arms (3)

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

Behavioral: SLIMM; Behavioral: Standard Resistance Training; Drug: 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

Behavioral: SLIMM; Behavioral: Guided Resistance Training; Drug: 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

Behavioral: SLIMM; Behavioral: Guided Resistance Training; Drug: Semaglutide

Interventions

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.

SLIMM + Guided RT + Placebo; SLIMM + Guided RT + Semaglutide; SLIMM + Standard RT + Placebo

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.

SLIMM + Standard RT + Placebo

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.

SLIMM + Guided RT + Placebo; SLIMM + Guided RT + Semaglutide

Placebo DRUG

Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.

SLIMM + Guided RT + Placebo; SLIMM + Standard RT + Placebo

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.

SLIMM + Guided RT + Semaglutide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Srinvasan Beddhu: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Stanford University: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Srinivasan Beddhu, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amara Sarwal, M.D.

CONTACT

801-585-9815; Amara.Sarwal@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 30, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)