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

Srinvasan Beddhu

Status and phase: Enrolling; Phase 2

Conditions: Chronic Kidney Diseases; Obesity

Treatments: Drug: Semaglutide; Behavioral: Guided Resistance Training; Behavioral: SLIMM; Behavioral: Standard Resistance Training; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05173714

138494

1R01DK128640-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

• 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 3 patient groups, including a placebo group

SLIMM + Standard RT + Placebo

Placebo Comparator group

Description:

SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, standard-of-care resistance training and oral placebo

Treatment:

Drug: Placebo

Behavioral: Standard Resistance Training

Behavioral: SLIMM

SLIMM + Guided RT + Placebo

Active Comparator group

Description:

SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral placebo

Treatment:

Drug: Placebo

Behavioral: SLIMM

Behavioral: Guided Resistance Training

SLIMM + Guided RT + Semaglutide

Experimental group

Description:

SLIMM intervention for 3 months, followed by a 9-month intervention of SLIMM, guided resistance training and oral semaglutide

Treatment:

Behavioral: SLIMM

Behavioral: Guided Resistance Training

Drug: Semaglutide