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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tirzepatide
DrugOnce weekly tirzepatide starting at 2.5 mg/weekly, with dose escalation monthly by 2.5 mg to a target dose of 10 mg/weekly or maximum tolerated
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TirzepatideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Appendicular lean muscle mass
Appendicular lean muscle mass assessed at baseline and at 6-month follow-up by dual-energy X-ray absorptiometry (DEXA)
Time frame
6 months2
Muscle Strength
Muscle strength assessed by isokinetic and isometric testing using Biodex dynamometry at baseline and at 6-month follow-up.
Time frame
6 months3
Lower Extremity Functional Capacity
Functional capacity will be measured using the 6-minute walk test (6MWT) at baseline and 6-month follow up visit.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov