NCT04684589CompletedPhase 2
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 16 Dec 2020
- Start date
- Mar 2021
- Primary completion date
- Jun 2025
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT04684589
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 99
- From Mar 2021 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current anti-hypertensive medication use, including diuretics
- Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
- Use of medications that strongly alter CYP3A4 activity
Other illness
- History of reaction to PDE-5 inhibitors
- Known HIV infection
- History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
- History of hearing loss
- History of priapism
- History of diabetes mellitus or use of anti-diabetic medications
- Individuals with circadian rhythm disorders, shift workers, or those who travel across time zones frequently
Lab values
- 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
Age
- Age \<19 or \> 50
Other
- BMI \< 30 kg/m2
- Systolic blood pressure (SBP) \< 100, \> 150 mmHg
- Current use of organic nitrates
- Known non-arteritic ischemic optic retinopathy (NAIOR)
- Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study
- Use in excess of four alcoholic drinks daily
- Known anemia (men, Hct \< 38% and women, Hct \<36%)
- Menopause
- Weight \> 300 pounds
Who the study is looking for
- Adults
- Obesity (BMI ≥ 30 kg/m2)
Age in the registry: 19 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.