Effects of tadalafil on fat metabolism in obese individuals
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
This study is testing if tadalafil can help obese adults burn fat more effectively over 12 weeks compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 50 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04684589 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded, placebo-controlled study investigates the impact of tadalafil on adipose tissue in obese adults. Participants will receive either tadalafil or a placebo for 12 weeks, with adipose metabolism assessed through MRI scans and adipose tissue aspiration to analyze gene expression. The study also includes a cooling protocol to evaluate the combined effects of tadalafil on fat metabolism, alongside monitoring body composition and physical activity. Participants will be compensated for their involvement in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 to 50 with a body mass index (BMI) of 30 kg/m2 or higher.
Not a fit: Patients with a BMI below 30 kg/m2 or those with certain cardiovascular or metabolic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into obesity treatment by potentially transforming fat tissue metabolism.
How similar studies have performed: While PDE5 inhibitors have been studied for various conditions, this specific approach to adipose metabolism is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Evan Brittain, MD, MSci — Vumc
- Study coordinator: Rashundra Oggs, NP
- Email: rashundra.n.oggs@vumc.org
- Phone: 615-875-7975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.