Primary outcomeMean· Baseline to 20 weeks
Lean Body Mass Change
| Group | Value (g) |
|---|---|
| Semaglutide and Lifestyle Intervention | -1730.6 |
| Lifestyle Intervention | -421 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Apr 2023
- Primary completion
- 20 May 2024
- Completion
- 20 May 2024
- First posted
- 27 Mar 2023
- Last update posted
- 4 May 2025
- Conditions
- Aging · Diabetes Mellitus, Type 2 · PreDiabetes · Overweight and Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202320242025
- Ph 4
Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults
NCT057865211 Apr 2023 to 20 May 2024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Semaglutide is a medication approved by the US Food and Drug Administration (FDA) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. This new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.
Interventions
- Semaglutide Injectable ProductDrug
- Lifestyle CounselingBehavioral
Arms2
Experimental
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.
Active comparator
Lifestyle intervention
Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program
Primary outcomes1
Outcomes the sponsor listed as primary.
Lean Body Mass Change
Time frame · Baseline to 20 weeks
Registry description
Determine if there is any change in lean body mass
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide and Lifestyle InterventionParticipants 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 | 0 / 10 | 0 / 10 | 6 / 10 |
| Lifestyle InterventionParticipants 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 | 0 / 10 | 0 / 10 | 1 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
0 studies on this page
Indexing hint: Clinical trial · 2024
Effect of Semaglutide on Physical Function, Body Composition, and Biomarkers of Aging in Older Adults With Overweight and Insulin Resistance: Protocol for an Open-Labeled Randomized Controlled Trial.
Cortes et al. 2024JMIR research protocolscited by 15
PMID 39269759PMC11437224DOI 10.2196/62667PUB-39269759
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 65 Years up to 90 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Older than 65
* Have prediabetes or diabetes
* BMI ≥ 27.0 kg/m2
* Living independently (not in assisted living or nursing home)
Exclusion Criteria:
* Have heart disease
* Have liver disease
* Smoke
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