Phase 2
N=125
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
Healthy · Obese
Bottom Line
View on ClinicalTrials.gov: NCT02819440 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day) — 1267; 1268 kcal/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tadalafil (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day) |
1267; 1268 | — |
| PRIMARY Insulin Sensitivity After 12 Weeks of Drug Therapy |
1.4; 1.5 | — |
| SECONDARY Physical Activity-induced Energy Expenditure (kcal/Day) |
3320; 3269 | — |
| SECONDARY Dual Energy X-Ray Absorptiometry (DEXA) (g) |
47; 50 | — |
| SECONDARY Quality of Life Using the Medical Outcomes Study Short-Form Health Survey (SF-36) Physical Component Score |
52.7; 51.0 | — |
| SECONDARY Change in cGMP/NP Ratio After 12 Weeks of Drug Therapy |
— | — |
| SECONDARY Maximal Oxygen Consumption |
883; 893 | — |
| SECONDARY Sexual Function |
23.9; 19.8 | — |
| SECONDARY Maximal Exercise Energy Expenditure (kcal/Day) |
4535; 4588 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults (ages 21-50)
- Obesity (BMI ≥ 30 kg/m2)
- Prediabetes on oral glucose tolerance test.
Exclusion Criteria
- Age 50
- BMI 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) 300 pounds
Data sourced from ClinicalTrials.gov (NCT02819440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.