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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT05786521
Collaborator
National Institute on Aging (NIA) (NIH)
20
Enrollment
1
Location
2
Arms
21.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Semaglutide Injectable Product
  • Behavioral: Lifestyle Counseling
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. 6 minute walking distance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Health San Antonio San Antonio Texas United States 78229

Sponsors and Collaborators

  • The University of Texas Health Science Center at San Antonio
  • National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tiffany Cortes, Assistant Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT05786521
Other Study ID Numbers:
  • 20220256HU
  • 5P30AG044271-08
First Posted:
Mar 27, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Overweight

Study Results

No Results Posted as of Apr 4, 2023