Trial Outcomes & Findings for Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults (NCT NCT05786521)
NCT ID: NCT05786521
Last Updated: 2025-05-04
Results Overview
Determine if there is any change in lean body mass
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 20 weeks
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Semaglutide and Lifestyle Intervention
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Semaglutide Injectable Product: Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
Lifestyle Intervention
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults
Baseline characteristics by cohort
| Measure |
Semaglutide and Lifestyle Intervention
n=10 Participants
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Semaglutide Injectable Product: Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
Lifestyle Intervention
n=10 Participants
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 4.85 • n=99 Participants
|
73.4 years
STANDARD_DEVIATION 4.98 • n=107 Participants
|
72.65 years
STANDARD_DEVIATION 4.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 20 weeksDetermine if there is any change in lean body mass
Outcome measures
| Measure |
Semaglutide and Lifestyle Intervention
n=10 Participants
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Semaglutide Injectable Product: Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
Lifestyle Intervention
n=10 Participants
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
|---|---|---|
|
Lean Body Mass Change
|
-1730.6 g
Interval -3063.0 to -398.0
|
-421 g
Interval -1745.0 to 911.0
|
Adverse Events
Semaglutide and Lifestyle Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Lifestyle Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Semaglutide and Lifestyle Intervention
n=10 participants at risk
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.
Semaglutide Injectable Product: Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
Lifestyle Intervention
n=10 participants at risk
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Lifestyle Counseling: Lifestyle Counseling will be provided throughout study intervention
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
6/10 • Number of events 7 • 20 weeks
|
10.0%
1/10 • Number of events 1 • 20 weeks
|
Additional Information
TIffany M Cortes, MD
University of Texas Health Science Center San Antonio
Phone: 210-450-3333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place