NCT01444651

A Trial of Tadalafil and Glycemic Traits

Phase 3 Randomized Trial of Tadalafil and Glycemic Traits

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Thomas J. Wang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 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).

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 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.

Conditions

• Cardiovascular Disease
• Insulin Resistance
• Glucose Intolerance
• Obesity

Interventions

Type	Name	Description
DRUG	Tadalafil	20 mg Tadalafil taken once a day for 3 months
DRUG	Placebo	Placebo tablet taken by mouth once a day for 3 months

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-10-03
• Last updated: 2017-01-30
• Results posted: 2017-01-30

Locations

1 site across 1 country: United States