At a glance
ClinicalIndex Comparison Record- ✓Age 21–50 years
- ✓Obesity with BMI ≥30 kg/m²
- ✓Prediabetes on oral glucose tolerance test
- ✕Systolic blood pressure <100 or >150 mmHg
- ✕Current use of antihypertensive medications or diuretics
- ✕Current use of organic nitrates
- ✕Current or prior use of PDE-5 inhibitors or known reaction to them
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
In Brief
A Phase 2 clinical trial evaluating Tadalafil and Placebo for Healthy and Obese. Completed, enrolled 141 participants across 1 site.
Detailed Summary
Obesity and its adverse cardiometabolic consequences are major public health problems. Several features of obesity contribute to the associated cardiovascular risk and are potential targets for intervention. These include insulin resistance and beta cell dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic health in individuals who are obese and insulin resistant.
Study Details
Timeline
Interventions
Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit.
100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit.