Recruiting NCT07226947
Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smartwatch activity and body composition monitor, General guidance on recommended exercise.
- Who it may be relevant to
- Registry conditions: Obesity, Body Composition. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)
Overview
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.
Interventions
- Device Smartwatch activity and body composition monitor
Participants will be provided a smartwatch to monitor their exercise and body composition - Behavioral General guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Primary outcome measures
- Lean mass (kg) [Time frame: 6 months]
Secondary outcome measures (12)
- Lean mass index (kg/m2) [Time frame: 6 months]
- Appendicular lean mass index (kg/m2) [Time frame: 6 months]
- Fat mass index (kg/m2) [Time frame: 6 months]
- Fat mass (kg) [Time frame: 6 months]
- Visceral adipose tissue (kg) [Time frame: 6 months]
- Lean mass/fat mass ratio [Time frame: 6 months]
- Fat free mass [Time frame: 6 months]
- Hand grip strength (kg) [Time frame: 6 months]
- 1-minute sit-to-stand [Time frame: 6 months]
- 6-minute walk test [Time frame: 6 months]
- Short Physical Performance Battery frailty score (total points) [Time frame: 6 months]
- Physical activity score [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Diabetes Research Center — Boston
Publications
- 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
Identifiers
NCT: NCT07226947 · 2025P001490