A Trial of Tadalafil and Glycemic Traits

Thomas J. Wang, MD

Status and phase

Completed

Phase 3

Conditions

Insulin Resistance

Obesity

Glucose Intolerance

Cardiovascular Disease

Treatments

Drug: Placebo

Drug: Tadalafil

Study type

Interventional

Funder types

Other

Identifiers

NCT01444651

2010P-001519

Details and patient eligibility

About

The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

Full description

This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.

The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.

The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.

Enrollment

73 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 18 years and < 50 years
BMI > 30 kg/m2
Fasting insulin > 10 uU/mL

Exclusion criteria

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 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%)