Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment

Официальное название

BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)

Обзор

The goal of this study is to learn if a smartwatch that measures activity level and body composition, combined with exercise reminders, can safely improve strength and muscle mass in people who recently started or are planning to start treatment with incretin therapy (liraglutide, semaglutide, tirzepatide or retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.

Вмешательства

• Устройство Smartwatch activity and body composition monitor
  Participants will be provided a smartwatch to monitor their exercise and body composition
• Поведенческое General guidance on recommended exercise
  Participants will receive general guidance on recommended exercise

Первичные конечные точки

• Lean mass (kg) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Lean mass index (kg/m2) [Срок оценки: 6 months]
• Appendicular lean mass index (kg/m2) [Срок оценки: 6 months]
• Fat mass index (kg/m2) [Срок оценки: 6 months]
• Fat mass (kg) [Срок оценки: 6 months]
• Visceral adipose tissue (kg) [Срок оценки: 6 months]
• Lean mass/fat mass ratio [Срок оценки: 6 months]
• Fat free mass [Срок оценки: 6 months]
• Hand grip strength (kg) [Срок оценки: 6 months]
• 1-minute sit-to-stand [Срок оценки: 6 months]
• 6-minute walk test [Срок оценки: 6 months]
• Short Physical Performance Battery frailty score (total points) [Срок оценки: 6 months]
• Physical activity score [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Age ≥ 18 years old at time of signing informed consent
• Started treatment with incretin therapy (liraglutide, semaglutide, tirzepatide, or retatrutide) within the past 2 months or planning to start this treatment

a. Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment

• Able to provide informed consent

Критерии исключения

• Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months
• BMI <25 kg/m2 at the time of screening
• Unable to participate in a regular physical exercise program
• Implanted pacemaker
• Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of 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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Diabetes Research Center — Boston

Публикации

• Locatelli JC, Costa JG, Haynes A, Naylor LH, Fegan PG, Yeap BB, Green DJ. Incretin-Based Weight Loss Pharmacotherapy: Can Resistance Exercise Optimize Changes in Body Composition? Diabetes Care. 2024 Oct 1;47(10):1718-1730. doi: 10.2337/dci23-0100. PMID 38687506
• Cesari M, Leeuwenburgh C, Lauretani F, Onder G, Bandinelli S, Maraldi C, Guralnik JM, Pahor M, Ferrucci L. Frailty syndrome and skeletal muscle: results from the Invecchiare in Chianti study. Am J Clin Nutr. 2006 May;83(5):1142-8. doi: 10.1093/ajcn/83.5.1142. PMID 16685058
• Srikanthan P, Horwich TB, Tseng CH. Relation of Muscle Mass and Fat Mass to Cardiovascular Disease Mortality. Am J Cardiol. 2016 Apr 15;117(8):1355-60. doi: 10.1016/j.amjcard.2016.01.033. Epub 2016 Feb 2. PMID 26949037
• Tyrovolas S, Haro JM, Mariolis A, Piscopo S, Valacchi G, Bountziouka V, Anastasiou F, Zeimbekis A, Tyrovola D, Foscolou A, Gotsis E, Metallinos G, Tur JA, Matalas A, Lionis C, Polychronopoulos E, Panagiotakos D. Skeletal muscle mass and body fat in relation to successful ageing of older adults: The multi-national MEDIS study. Arch Gerontol Geriatr. 2016 Sep-Oct;66:95-101. doi: 10.1016/j.archger.20 PMID 27266673
• Tempia Valenta S, Nicastri A, Marcolini F, Petroni ML, Perazza F, Beghelli V, et al. The Impact of GLP-1 Receptor Agonists (GLP-1 RAs) on Mental Health: A Systematic Review. Current Treatment Options in Psychiatry. 2024 Sep 18;11(4):310-57.
• Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26. PMID 37366315
• Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)0120 PMID 37385275
• Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4. PMID 35658024

Идентификаторы

NCT: NCT07226947 · 2025P001490

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗