Effect of PDE5 Inhibition on Adipose Metabolism in Humans

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5 inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount of adipose to measure gene expression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: National Institutes of Health (NIH)
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• Adults

• Obesity (BMI ≥ 30 kg/m2)

Exclusion Criteria:

• Age <19 or > 50

• BMI < 30 kg/m2

• Systolic blood pressure (SBP) < 100, > 150 mmHg

• Current anti-hypertensive medication use, including diuretics

• Current use of organic nitrates

• Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)

• History of reaction to PDE-5 inhibitors

• Known HIV infection

• Use of medications that strongly alter CYP3A4 activity

• History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure

• Known non-arteritic ischemic optic retinopathy (NAIOR)

• History of hearing loss

• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation

• Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal

• Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study

• History of priapism

• Use in excess of four alcoholic drinks daily

• History of diabetes mellitus or use of anti-diabetic medications

• Known anemia (men, Hct < 38% and women, Hct <36%)

• Menopause

• Weight > 300 pounds

• Individuals with circadian rhythm disorders, shift workers, or those who travel across time zones frequently