Chronic Kidney DiseasesPhase 2NCT05173714
Sit Less, Interact and Move More (SLIMM) 2 Study
A Phase 2 study testing SLIMM, Standard Resistance Training and Guided Resistance Training in people with Chronic Kidney Diseases and Obesity, run by Srinvasan Beddhu at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Obesity
- What is being tested?
- SLIMM, Standard Resistance Training and Guided Resistance Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2021to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Judy Carle, 801-585-1113, jcarle@hsc.utah.edu
Srinivasan Beddhu, M.D.
- Recruiting
Stanford University
Stanford, California, 94305
Edison Lee, 650-497-7526, elee125@stanford.edu
Glenn M Chertow, M.D.
About this study
- 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
- Being tested
- SLIMM, Standard Resistance Training, Guided Resistance Training, Placebo, Semaglutide
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLIMMBehavioural
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.
Standard Resistance TrainingBehavioural
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 TrainingBehavioural
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.
PlaceboDrug
Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.
SemaglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: SLIMM; Behavioral: Guided Resistance Training; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Randomization to 12 Months
Secondary outcomes (4)
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.
Measured: Randomization to 12 Months
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.
Measured: 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
Measured: 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
Measured: Randomization to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Srinvasan Beddhu
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Responsible party
- Sponsor-investigator, Srinvasan Beddhu, University of Utah
- Investigators
- Srinivasan Beddhu, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173714
- Sponsor's protocol ID
- 138494
- Other IDs
- 1R01DK128640-01
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sit Less, Interact and Move More (SLIMM) 2 Study
- ClinicalTrials.gov ID
- NCT05173714
- Acronym / sponsor ID
- 138494
- Conditions
- Chronic Kidney Diseases, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Srinvasan BeddhuUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLIMM + Standard RT + Placebo | Placebo comparator | Behavioral: SLIMM, Behavioral: Standard Resistance Training, Drug: PlaceboSLIMM 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 | Behavioral: SLIMM, Behavioral: Guided Resistance Training, Drug: PlaceboSLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo |
| SLIMM + Guided RT + Semaglutide | Experimental | Behavioral: SLIMM, Behavioral: Guided Resistance Training, Drug: SemaglutideSLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLIMMIncrease 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. | Behavioural | SLIMM + Guided RT + Placebo, SLIMM + Guided RT + Semaglutide, SLIMM + Standard RT + Placebo |
| Standard Resistance TrainingParticipants 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. | Behavioural | SLIMM + Standard RT + Placebo |
| Guided Resistance TrainingSupervised 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. | Behavioural | SLIMM + Guided RT + Placebo, SLIMM + Guided RT + Semaglutide |
| PlaceboOral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period. | Drug | SLIMM + Guided RT + Placebo, SLIMM + Standard RT + Placebo |
| SemaglutideOral 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. | Drug | SLIMM + Guided RT + Semaglutide |
Primary outcome
Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization
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
4 secondary outcomes
Average Change in Steps per Day at Months 8, 10 and 12 from Randomization
Time frame: Randomization to 12 Months
Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization
Time frame: Randomization to 12 Months
Average Change in Six-Minute Walk at Months 6 and 12 from Randomization
Time frame: Randomization to 12 Months
Average Change in Body Fat % at Months 6 and 12 from Randomization
Time frame: Randomization to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Srinivasan Beddhu, M.D. principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLIMM, Standard Resistance Training and Guided Resistance Training in people with Chronic Kidney Diseases and Obesity, run by Srinvasan Beddhu at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amara Sarwal, M.D. (801-585-9815, Amara.Sarwal@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization (time frame: Randomization to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.