A Trial of Tadalafil and Glycemic Traits
This study is currently recruiting participants.
Verified April 2012 by Massachusetts General Hospital
Sponsor:
Thomas J. Wang, MD
Information provided by (Responsible Party):
Thomas J. Wang, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01444651
First received: August 3, 2011
Last updated: April 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Insulin Resistance Glucose Intolerance Obesity |
Drug: Tadalafil Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 3 Randomized Trial of Tadalafil and Glycemic Traits |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Insulin Resistance, as measured by HOMA-IR [ Time Frame: 3 months ] [ Designated as safety issue: No ]The primary endpoint is defined as the change in insulin resistance (as measured by HOMA-IR).
Secondary Outcome Measures:
- Insulin Sensitivity, as measured by the Matsuda index [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in insulin sensitivity (as measured by the Matsuda index).
- Endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]reactive hyperemia index, using EndoPAT device
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tadalafil
20 mg Tadalafil tablet taken by mouth once a day for 3 months
|
Drug: Tadalafil
20 mg Tadalafil taken once a day for 3 months
Other Name: Adcirca, Cialis
|
|
Placebo Comparator: Placebo
Placebo tablet taken by mouth once a day for 3 months
|
Drug: Placebo
Placebo tablet taken by mouth once a day for 3 months
Other Name: Sugar pill
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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%)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444651
Contacts
| Contact: Allicia Ryan, B.A. | (617)-643-7618 | Aryan4@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Allicia Ryan aryan4@partners.org | |
Sponsors and Collaborators
Thomas J. Wang, MD
Investigators
| Principal Investigator: | Thomas J Wang, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Thomas J. Wang, MD, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01444651 History of Changes |
| Other Study ID Numbers: | 2010P-001519 |
| Study First Received: | August 3, 2011 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Tadalafil Phosphodiesterase 5 Inhibitors Cyclic Guanylyl Monophosphate Pathway Pharmacologic Actions Vasodilator Agents |
Cardiovascular Agents Obesity Glycemic Traits Insulin Resistance Glucose Metabolism |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Insulin Resistance Obesity Glucose Intolerance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Hyperglycemia Cardiovascular Agents Tadalafil Phosphodiesterase 5 Inhibitors Therapeutic Uses Pharmacologic Actions Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013