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Clinical Trials/NCT07226947
NCT07226947RecruitingNot Applicable

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

Massachusetts General Hospital2 sites in 1 country100 target enrollmentStarted: November 24, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
Lean mass (kg)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Lean mass (kg)

Time Frame: 6 months

Dual-energy X-ray absorptiometry (DXA) body composition measure

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melissa Susan Putman

Principal Investigator

Massachusetts General Hospital

Study Sites (2)

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