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Effect of PDE5 Inhibition on Adipose Metabolism in Humans

CompletedPhase 2

Sponsor: Vanderbilt University Medical Center

Conditions: Obesity

Interventions: Tadalafil 20 MG, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 19 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Nashville, Tennessee, United States