COMPLETED

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Quick Facts

Study Start:2021-03-16

Study Completion:2025-06-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04684589

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.

Ages Eligible for Study:19 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Evan Brittain, MD, MSci

PRINCIPAL_INVESTIGATOR

VUMC

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Evan Brittain, MD, MSci, PRINCIPAL_INVESTIGATOR, VUMC

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

Study Start Date2021-03-16

Study Completion Date2025-06-24

Study Record Updates

Study Start Date2021-03-16

Study Completion Date2025-06-24

Terms related to this study

Additional Relevant MeSH Terms

Obesity