A Trial of Tadalafil and Glycemic Traits

NCT ID: NCT01444651

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-03-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tadalafil

20 mg Tadalafil tablet taken by mouth once a day for 3 months

Group Type: ACTIVE_COMPARATOR

Tadalafil

Intervention Type: DRUG

20 mg Tadalafil taken once a day for 3 months

Placebo

Placebo tablet taken by mouth once a day for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet taken by mouth once a day for 3 months

Interventions

Tadalafil

20 mg Tadalafil taken once a day for 3 months

Intervention Type: DRUG

Placebo

Placebo tablet taken by mouth once a day for 3 months

Intervention Type: DRUG

Other Intervention Names

Adcirca, Cialis; Sugar pill

Eligibility Criteria

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%)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas J. Wang, MD

OTHER

Sponsor Role: lead

Responsible Party

Thomas J. Wang, MD

Associate Professor of Medicine, Harvard Medical School

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas J Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Ho JE, Arora P, Walford GA, Ghorbani A, Guanaga DP, Dhakal BP, Nathan DI, Buys ES, Florez JC, Newton-Cheh C, Lewis GD, Wang TJ. Effect of phosphodiesterase inhibition on insulin resistance in obese individuals. J Am Heart Assoc. 2014 Sep 11;3(5):e001001. doi: 10.1161/JAHA.114.001001.

Reference Type: DERIVED

PMID: 25213566 (View on PubMed)

Other Identifiers

2010P-001519

Identifier Type: -

Identifier Source: org_study_id