Status:
COMPLETED
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Obesity
Eligibility:
All Genders
19-50 years
Phase:
PHASE2
Brief 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 magnet...
Detailed Description
The purpose of this study is to test whether tadalafil causes subcutaneous adipose tissue to have a "beige" phenotype. Participants will be randomized to either placebo or tadalafil for 12 weeks. Inve...
Eligibility Criteria
Inclusion
- Adults
- Obesity (BMI ≥ 30 kg/m2)
Exclusion
- 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
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04684589
Start Date
March 16 2021
End Date
June 24 2025
Last Update
August 29 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203