Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Hispanic Adults

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tirzepatide on muscle and vascular health in older Hispanic adults who are obese. Tirzepatide is a new treatment that has been shown to help people lose weight and manage blood sugar levels, which is important for preventing diabetes and improving heart health. However, there are concerns that while it helps with weight loss, it might lead to loss of muscle mass, which can make older adults weaker and more prone to frailty. The trial aims to see how tirzepatide affects muscle mass and strength over a six-month period in older Hispanic adults, and whether changes in muscle health relate to their overall physical ability.

To participate in this trial, you need to be a self-reported Hispanic man or postmenopausal woman who is at least 50 years old and has a body mass index (BMI) of 30 or higher, which indicates obesity. You should not have diabetes or be taking medication for it, and you must be willing to follow the study's procedures. If you join the study, you will receive tirzepatide for six months and take part in assessments to measure your muscle health and physical function. This trial is important as it seeks to better understand how this treatment works specifically in the aging Hispanic community, which is often affected by obesity and its related health issues.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Self-reported Hispanic ethnicity.
• • Men and postmenopausal women aged 50 years or older.
• • Body Mass Index (BMI) ≥30 kg/m².
• • Untreated HbA1c \<6.5% at baseline.
• • Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
• • Able to provide informed consent and participate in all study assessments.
• • Exclusion Criteria
• • Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
• • Body Mass Index (BMI) ≥ 40 kg/m².
• • Moderate to severe gastroesophageal reflux disease based on patient history.
• • Inability to comply with the treatment protocol or to understand the consent form.
• • Chronic Kidney Disease (CKD) Stage 4.
• • Aspartate aminotransferase (AST) \> 33 U/L or alanine aminotransferase (ALT) \> 36 U/L.
• • Active pregnancy.
• • Personal or family history of medullary thyroid carcinoma.
• • Personal or family history of multiple endocrine neoplasia type 2 syndrome.
• • Personal history of gastroparesis.
• • Personal history of diabetic retinopathy.
• • Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.
• • Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.
• • Concomitant treatment with GLP-1 receptor agonist therapy