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

Primary Purpose

Aging, Diabetes Mellitus, Type 2, PreDiabetes

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Semaglutide Injectable Product

Lifestyle Counseling

About this trial

This is an interventional other trial for Aging

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UT Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide and lifestyle intervention

Lifestyle intervention

Arm Description

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.

Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program

Outcomes

Primary Outcome Measures

6 minute walking distance

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05786521

First Posted

March 2, 2023

Last Updated

April 3, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05786521

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging, Diabetes Mellitus, Type 2, PreDiabetes, Overweight and Obesity

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide and lifestyle intervention

Arm Type

Experimental

Arm Description

Arm Title

Lifestyle intervention

Arm Type

Active Comparator

Arm Description

Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program

Intervention Type

Drug

Intervention Name(s)

Semaglutide Injectable Product

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle Counseling

Intervention Description

Lifestyle Counseling will be provided throughout study intervention

Primary Outcome Measure Information:

Title

6 minute walking distance

Description

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.

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tiffany M Cortes, MD

Phone

210-450-3333

cortest@uthscsa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiffany M Cortes, MD

Organizational Affiliation

UT Health San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Health San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tiffany M Cortes, MD

Phone

210-409-3333

cortest@uthscsa.edu

First Name & Middle Initial & Last Name & Degree

Tiffany M Cortes, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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