GLP-1 Receptor Agonists for the Reduction of Atherosclerotic Cardiovascular Risk in Patients With Type 2 Diabetes.
Nikolaus Marx, Mansoor Husain, Michael Lehrke...
https://pubmed.ncbi.nlm.nih.gov/36508493Actively Recruiting
Phase 2
Age: 50Years +
All Genders
ID06811324
The Effects of Tirzepatide on Muscle and Vascular Function in Obese Older Adults
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of tirzepatide, a new medication approved for type 2 diabetes and obesity, on muscle mass and function in older adults with obesity. The study focuses on people aged 50 and older, especially since weight loss from tirzepatide might include loss of muscle, which can cause weakness and frailty. The study is a pilot, single-arm, open-label trial conducted in South Texas, where obesity and related diseases are common among aging adults. Participants will self-administer tirzepatide once a week by injection, starting at 2.5 mg with dose increases monthly up to 10 mg or the highest tolerated dose. The treatment period lasts for 6 months. The trial evaluates how tirzepatide affects muscle mass, strength, and vascular health during this time. During the study, participants will undergo assessments of muscle mass, muscle strength, and lower extremity function at the start and after 6 months of treatment. Researchers will monitor changes in these outcomes to understand the impact of tirzepatide on muscle and vascular health. Participants are expected to comply with fasting and other study procedures, and the total duration of involvement is 6 months.
CONDITIONS
Brief Title
Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and postmenopausal women aged 50 years or older
- Body Mass Index (BMI) of 30 kg/m² or higher
- Untreated hemoglobin A1c less than 6.5% at baseline
- Willingness and ability to follow all study procedures, including fasting when required
- Able to give informed consent and participate in all study assessments
You will not qualify if you...
- Active type 2 diabetes mellitus or use of glucose-lowering medications
- Body Mass Index (BMI) of 40 kg/m² or higher
- Moderate to severe gastroesophageal reflux disease
- Unable to comply with treatment protocol or understand consent
- Chronic Kidney Disease Stage 4
- Elevated liver enzymes (AST > 33 U/L or ALT > 36 U/L)
- Active pregnancy
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome
- Personal history of gastroparesis or diabetic retinopathy
- Known serious allergy to tirzepatide or GLP-1 receptor agonists
- Current treatment with GLP-1 receptor agonist therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive weekly self-administered injections of Tirzepatide with dose escalation monthly up to a target dose or maximum tolerated dose.
Weekly visits for 6 months
Trial Site Locations
Total: 1 location
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
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Research Team
S
Suha Soni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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