A Trial of Tadalafil and Glycemic Traits
Tracking Information | |||||
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First Received Date ICMJE | August 3, 2011 | ||||
Last Updated Date | April 26, 2012 | ||||
Start Date ICMJE | August 2011 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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). |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01444651 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Trial of Tadalafil and Glycemic Traits | ||||
Official Title ICMJE | Phase 3 Randomized Trial of Tadalafil and Glycemic Traits | ||||
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). |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 100 | ||||
Estimated Completion Date | December 2012 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01444651 | ||||
Other Study ID Numbers ICMJE | 2010P-001519 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Thomas J. Wang, MD, Massachusetts General Hospital | ||||
Study Sponsor ICMJE | Thomas J. Wang, MD | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Massachusetts General Hospital | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |