~69 spots leftby Dec 2027

SLIMM + Semaglutide for Kidney Disease

Recruiting in Palo Alto (17 mi)
+1 other location
SB
Overseen bySrinivasan Beddhu, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Srinvasan Beddhu
Must be taking: Semaglutide
Must not be taking: GLP-1 receptor agonists
Disqualifiers: Type 1 diabetes, Bariatric surgery, Heart failure, others
Prior Safety Data

Trial Summary

What is the purpose of this trial?

* 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any GLP-1 receptor agonist within 30 days before joining the study.

What data supports the effectiveness of the drug semaglutide for kidney disease?

Research shows that semaglutide, a drug used for type 2 diabetes, can help slow the progression of kidney disease by improving blood sugar control, reducing blood pressure, and decreasing protein in the urine. It also helps with weight loss, which can be beneficial for kidney health.12345

Is semaglutide safe for humans?

Semaglutide, used for type 2 diabetes, has been shown to be generally safe in humans, including those with kidney issues, with common side effects like nausea and vomiting. It has been tested in various forms, such as oral and injectable, and is considered safe for people with advanced kidney disease.12567

How is the drug Semaglutide unique for treating kidney disease?

Semaglutide is unique for treating kidney disease because it is a once-weekly injection that not only helps control blood sugar levels but also shows potential benefits for kidney health, such as reducing albuminuria (protein in urine) and preserving kidney function, which are not typical effects of standard diabetes medications.35789

Research Team

SB

Srinivasan Beddhu, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

The SLIMM 2 study is for adults with chronic kidney disease who are overweight, can walk a certain distance, and have moderate to severe reduction in kidney function. Participants need internet access and the ability to do resistance training but cannot be on oxygen therapy or have had recent major medical procedures.

Inclusion Criteria

Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network), desktop or laptop
I can walk between 300 to 600 meters in six minutes.
My kidney function is moderately to severely reduced.
See 2 more

Exclusion Criteria

Vulnerable populations- pregnant or incarcerated
I use supplemental oxygen during the day.
I use devices like canes or walkers to help me move around.
See 13 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SLIMM Intervention

Participants undergo the SLIMM intervention targeting sedentary behavior

3 months

Extended Intervention

Participants continue with SLIMM, resistance training, and either placebo or semaglutide

9 months

Follow-up

Participants are monitored for changes in sleep, quality of life, inflammation markers, and physical performance

12 months

Treatment Details

Interventions

  • Guided Resistance Training (Behavioral)
  • Placebo (Drug)
  • Semaglutide (GLP-1 Receptor Agonist)
  • SLIMM (Behavioral)
  • Standard Resistance Training (Behavioral)
Trial OverviewThis trial tests whether guided resistance training and semaglutide (a diabetes/weight loss medication) can help people with kidney disease reduce sedentary behavior by improving muscle strength and physical function as part of the SLIMM intervention.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: SLIMM + Guided RT + SemaglutideExperimental Treatment3 Interventions
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide
Group II: SLIMM + Guided RT + PlaceboActive Control3 Interventions
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo
Group III: SLIMM + Standard RT + PlaceboPlacebo Group3 Interventions
SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo

Semaglutide is already approved in Canada, Japan for the following indications:

🇨🇦
Approved in Canada as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇯🇵
Approved in Japan as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?

Srinvasan Beddhu

Lead Sponsor

Trials
3
Patients Recruited
290+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2513
Patients Recruited
4,366,000+

Stanford University

Collaborator

Trials
2527
Patients Recruited
17,430,000+

Findings from Research

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment.Granhall, C., Søndergaard, FL., Thomsen, M., et al.[2021]
In a study involving 56 subjects with varying degrees of renal impairment, semaglutide exposure was found to be similar in those with mild to moderate renal impairment and end-stage renal disease compared to those with normal kidney function, suggesting it is safe for use in these populations.
The drug was well-tolerated overall, with no significant safety concerns or serious adverse events reported, indicating that dose adjustments for semaglutide may not be necessary for patients with renal impairment.
Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.Marbury, TC., Flint, A., Jacobsen, JB., et al.[2018]
Influence of chronic kidney disease and its severity on the efficacy of semaglutide in type 2 diabetes patients: a multicenter real-world study.García de Lucas, MD., Caballero, I., Fernández-García, JC., et al.[2023]
Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.Mann, JFE., Hansen, T., Idorn, T., et al.[2020]
Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis.De la Flor, JC., Lorenzo, JD., Marschall, A., et al.[2022]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)].Paquot, N.[2022]
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)].Scheen, AJ.[2019]
Nephroprotective Effects of Semaglutide as Mono- and Combination Treatment with Lisinopril in a Mouse Model of Hypertension-Accelerated Diabetic Kidney Disease.Dalbøge, LS., Christensen, M., Madsen, MR., et al.[2022]
Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.Heerspink, HJL., Apperloo, E., Davies, M., et al.[2023]

References

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. [2021]
Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. [2018]
Influence of chronic kidney disease and its severity on the efficacy of semaglutide in type 2 diabetes patients: a multicenter real-world study. [2023]
Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials. [2020]
Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis. [2022]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]
Nephroprotective Effects of Semaglutide as Mono- and Combination Treatment with Lisinopril in a Mouse Model of Hypertension-Accelerated Diabetic Kidney Disease. [2022]
Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. [2023]