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

Not Applicable

Recruiting

• Conditions: Obesity; Body Composition

• Registration Number: NCT07226947
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-06
• Study First Submitted QC: 2025-11-10
• Last Update Submitted: 2025-11-10
• Study First Posted: 2025-11-12
• Last Update Posted: 2025-11-12
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lean mass (kg)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure

Secondary Outcome Measures

Name	Time	Method
Fat mass index (kg/m2)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Fat mass (kg)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Lean mass index (kg/m2)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Appendicular lean mass index (kg/m2)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Visceral adipose tissue (kg)	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Lean mass/fat mass ratio	6 months	Dual-energy X-ray absorptiometry (DXA) body composition measure
Fat free mass	6 months	Bioimpedance analysis body composition measure
Hand grip strength (kg)	6 months	Function strength measurement
1-minute sit-to-stand	6 months	Number of sit-to-stand repetitions in one minute
6-minute walk test	6 months	Distance walked in six minutes
Short Physical Performance Battery frailty score (total points)	6 months	Physical functioning test consisting of standing balance, gait speed, and repeated chair stands
Physical activity score	6 months	International Physical Activity Questionnaire (IPAQ)

Trial Locations

Locations (1)

Diabetes Research Center; 🇺🇸 Boston, Massachusetts, United States