Status:
COMPLETED
A Trial of Tadalafil and Glycemic Traits
Lead Sponsor:
Thomas J. Wang, MD
Conditions:
Cardiovascular Disease
Insulin Resistance
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
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 fo...
Detailed 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 d...
Eligibility Criteria
Inclusion
- Age \> 18 years and \< 50 years
- BMI \> 30 kg/m2
- Fasting insulin \> 10 uU/mL
Exclusion
- 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%)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01444651
Start Date
August 1 2011
End Date
March 1 2013
Last Update
January 30 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States