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:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Lean mass (kg)
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
Melissa Susan Putman
Principal Investigator
Massachusetts General Hospital
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Physical Activity and Cognition StudyAgingNCT02773121Boston University28
Recruiting
Not Applicable
Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation ClientsCardiac RehabilitationPhysical ActivityNCT05795036AdventHealth University46
Enrolling By Invitation
Not Applicable
Activity Monitors as a Measure of Physical Function in Degenerative Cervical MyelopathyCervical MyelopathyNCT04498806University of Utah200
Recruiting
Not Applicable
Monitoring and Guidance of Physical Activity During the Maintenance Phase of Cardiac Rehabilitation: the Antwerp Activity IndexNCT07211282University Hospital, Antwerp318
Completed
Phase 1
Activity Tracking Study in Healthy Volunteers (MK-0000-419)NCT06833879Merck Sharp & Dohme LLC12
