Effect of PDE5 Inhibition on Adipose Metabolism in Humans
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.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 16 March 2021
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 19 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 December 2020
  • First Submitted that Met QC Criteria 21 December 2020
  • First Posted 24 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024