A Trial of Tadalafil and Glycemic Traits
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Peripheral Vascular Disease, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/1/2014 |
| Start Date: | August 2011 |
| End Date: | December 2012 |
| Contact: | Allicia Ryan, B.A. |
| Email: | Aryan4@partners.org |
| Phone: | (617)-643-7618 |
Phase 3 Randomized Trial of Tadalafil and Glycemic Traits
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).
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).
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.
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.
Inclusion Criteria:
- Age > 18 years and < 50 years
- BMI > 30 kg/m2
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%)
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