A Trial of Tadalafil and Glycemic Traits

Obesity Clinical Trial

Official title:

Phase 3 Randomized Trial of Tadalafil and Glycemic Traits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444651
• Other study ID #: 2010P-001519
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2011
• Last updated: February 5, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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%)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Glucose Intolerance
• Insulin Resistance
• Obesity

Intervention

Drug:
• Tadalafil
20 mg Tadalafil taken once a day for 3 months
• Placebo
Placebo tablet taken by mouth once a day for 3 months

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Thomas J. Wang, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Resistance, as measured by HOMA-IR	The primary endpoint is defined as the change in insulin resistance (as measured by HOMA-IR).	3 months	No
Secondary	Insulin Sensitivity, as measured by the Matsuda index	Change in insulin sensitivity (as measured by the Matsuda index).	3 months	No
Secondary	Endothelial function	reactive hyperemia index, using EndoPAT device	3 months	No
Secondary	Insulin sensitivity, as measured by the Stumvoll sensitivity index	Change in insulin sensitivity (as measured by the Stumvoll index)	3 months	No
Secondary	Pancreatic beta-cell function, as measured by HOMA-B	Change in pancreatic beta-cell function	3 months	No
Secondary	Insulin release, as measured by the insulinogenic index	Change in insulin release	3 months	No
Secondary	Composite of insulin resistance and sensitivity, as measured by the oral disposition index	Change in composite of insulin resistance and sensitivity	3 months	No
Secondary	Arterial stiffness, as measured by applanation tonometry	Change in arterial stiffness	3 months	No