RECRUITING

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Description

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
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Related Conditions:

Obesity

Study Overview

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Study Details

Study overview

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.

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults
  • * Obesity (BMI ≥ 30 kg/m2)
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vanderbilt University Medical Center,

Evan Brittain, MD, MSci, PRINCIPAL_INVESTIGATOR, VUMC

Study Record Dates

2025-12