Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID07226947

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

Led by Massachusetts General Hospital · Updated on 2025-12-30

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

S

Samsung

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying whether using a smartwatch that tracks activity levels and body composition, along with exercise reminders, can safely help improve strength and muscle mass in people who have recently started or plan to start treatment with incretin therapy medications called GLP-1 receptor agonists (liraglutide, semaglutide, tirzepatide, or retatrutide). These medications are used to manage conditions such as obesity and body composition changes. Participants will be randomly assigned to one of two groups. One group will receive a smartwatch to monitor their exercise and body composition, with exercise goals set and reminders provided on the device. The other group will receive general guidance on recommended exercise without the smartwatch. This study does not use blinding and follows participants over six months. During the study, participants will have their lean mass and other body composition measures checked at six months. Assessments will include hand grip strength, physical performance tests like the 1-minute sit-to-stand and 6-minute walk test, and physical activity scores. Researchers will monitor these outcomes to evaluate changes in muscle and fat mass and overall physical function throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older 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
  • Switching GLP1-RA therapies due to inadequate response to prior treatment are eligible
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Current pregnancy or plans to become pregnant in the next 6 months
  • Body mass index (BMI) less than 25 kg/m2 at screening
  • Unable to participate in a regular physical exercise program
  • Implanted pacemaker
  • Any factors deemed by the principal investigator to interfere with safe study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive either a smartwatch to monitor activity and body composition with exercise goals and reminders or general guidance on recommended exercise while undergoing incretin therapy.

Regular visits during the 6 months of treatment

Trial Site Locations

Total: 1 location

1

Diabetes Research Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

B

Ben O Brenner, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Incretin-Based Weight Loss Pharmacotherapy: Can Resistance Exercise Optimize Changes in Body Composition?

João Carlos Locatelli, Juliene Gonçalves Costa, Andrew Haynes...

https://pubmed.ncbi.nlm.nih.gov/38687506

Skeletal muscle mass and body fat in relation to successful ageing of older adults: The multi-national MEDIS study.

Stefanos Tyrovolas, Josep-Maria Haro, Anargiros Mariolis...

https://pubmed.ncbi.nlm.nih.gov/27266673

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.

W Timothy Garvey, Juan P Frias, Ania M Jastreboff...

https://pubmed.ncbi.nlm.nih.gov/37385275