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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging 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 among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older 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 adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tirzepatide

Treatment groups

20 Participants
are divided into 1 treatment group