Clinical trial NCT06811324: Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Hispanic Adults
Official title: The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Hispanic Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity Prevention
Sarcopenia in Elderly
Cardiovascular Function
GLP - 1
Weight Loss
Hispanic or Latino
Minorities
Keywords: Tirzepatide
GLP-1
Hispanics
Obesity
Sarcopenia
Cardiovascular Function
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging Hispanic community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide in the Hispanic community has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older Hispanic adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older Hispanic adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Detailed description: This study is a pilot, single-arm, open-label clinical trial to evaluate the effects of Tirzepatide on muscle mass, strength, and vascular health among older Hispanic adults with obesity. This study is particularly important because Hispanic individuals are disproportionately affected by obesity and related health issues, including type 2 diabetes and cardiovascular conditions, which can lead to rapid aging and increased frailty. Tirzepatide is a new FDA approved medication that promotes weight loss and improves health by targeting specific pathways in the body. While it has been shown to be effective in managing weight and blood sugar levels, there is less information about the kind of weight loss it induces, and how weight loss impacts measures of muscle mass, strength and mobility. This is especially concerning for older adults, as losing muscle mass can lead to weakness, falls, and disability.

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

Primary outcomes:
measure: Appendicular lean muscle mass
timeFrame: 6 months
measure: Muscle Strength
timeFrame: 6 months
measure: Lower Extremity Functional Capacity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Shreya Rao, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Elena Volpi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Tiffany Cortes, MD
role: STUDY_DIRECTOR
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