Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment
NCT ID: NCT07226947
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-30
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Smartwatch activity monitor
Participants will be provided a smartwatch to monitor activity and body composition monitor. They will also have exercise goals set with reminders on the watch.
Smartwatch activity and body composition monitor
Participants will be provided a smartwatch to monitor their exercise and body composition
General guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Usual guidance
Participants will receive general guidance on recommended exercise
General guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Interventions
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Smartwatch activity and body composition monitor
Participants will be provided a smartwatch to monitor their exercise and body composition
General guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Able to provide informed consent
Exclusion Criteria
2. BMI \<25 kg/m2 at the time of screening
3. Unable to participate in a regular physical exercise program
4. Implanted pacemaker
5. Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study
18 Years
99 Years
ALL
No
Sponsors
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Samsung
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Melissa Susan Putman
Principal Investigator
Principal Investigators
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Melissa Putman, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Diabetes Research Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Ben O Brenner, BS
Role: primary
Grace Kuropatkin, BS
Role: backup
References
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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.
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.
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.
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.2016.04.017. Epub 2016 May 9.
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.
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)01200-X. Epub 2023 Jun 26.
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.
Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
Related Links
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Recruitment website for this study
Other Identifiers
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2025P001490
Identifier Type: -
Identifier Source: org_study_id