Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults

March 21, 2024 updated by: Tiffany Cortes, The University of Texas Health Science Center at San Antonio

The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Semaglutide and Lifestyle Counseling
Behavioral: Lifestyle Counseling
Lifestyle Counseling will be provided throughout study intervention
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
Behavioral: Lifestyle Counseling
Lifestyle Counseling will be provided throughout study intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walking distance
Time Frame: 20 weeks
Determine if there is any change in 6 minute walking distance at end of study. Participants are timed to see how far they can walk in 6 minutes. Distance walked will be measured in meters.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Tiffany M Cortes, MD, UT Health San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220256HU
  • 5P30AG044271-08 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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