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

Обзор

* 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.

Вмешательства

• Поведенческое SLIMM
  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.
• Поведенческое Standard Resistance Training
  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.
• Поведенческое Guided Resistance Training
  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.
• Препарат Placebo
  Oral placebo tablets (matching the experimental semaglutide) will be administered from the first through ninth months of the drug intervention period.
• Препарат Semaglutide
  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.

Первичные конечные точки

• Average Change in Sedentary Duration at Months 8, 10 and 12 from Randomization [Срок оценки: Randomization to 12 Months]

Вторичные конечные точки (4)

• Average Change in Steps per Day at Months 8, 10 and 12 from Randomization [Срок оценки: Randomization to 12 Months]
• Average Change in Stepping Duration at Months 8, 10 and 12 from Randomization [Срок оценки: Randomization to 12 Months]
• Average Change in Six-Minute Walk at Months 6 and 12 from Randomization [Срок оценки: Randomization to 12 Months]
• Average Change in Body Fat % at Months 6 and 12 from Randomization [Срок оценки: Randomization to 12 Months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Stanford University — Stanford
• University of Utah — Salt Lake City

Идентификаторы

NCT: NCT05173714 · 138494 · 1R01DK128640-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗