The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2006 | ||||
| Last Updated Date | January 31, 2006 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction | ||||
| Official Title ICMJE | The Incidence and Treatment of Insulin Resistance Among Men With Erectile | ||||
| Brief Summary | Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls. |
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| Detailed Description | Insulin is a hormone produced by the body that lets sugar into the cells, where it is used for energy. Insulin resistance occurs when the body’s cells have a decreased ability to react to insulin. This leads to an increase in insulin secretion. Over time, insulin resistance can lead to higher levels of sugar in the blood (diabetes), and can also contribute to obesity, high blood pressure, high cholesterol levels and heart disease. There are no simple tests to actually diagnose insulin resistance. Currently, the glucose tolerance test is used to diagnose IR, but it involves several blood draws over a 2-hour period. Another purpose of this study is to compare a blood test involving only one blood draw to the 2-hour glucose tolerance test, which involves several blood draws over a 2-hour period. It is well known that diabetes often leads to erectile dysfunction. Because insulin resistance occurs before diabetes, it is possible that erectile dysfunction may occur in some individuals while they have insulin resistance, but before they develop diabetes. If this is true, it might be possible to use erectile dysfunction as a sign of insulin resistance, which may lead to more timely treatment of insulin resistance and may delay or prevent the development of diabetes, and the other problems mentioned above. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00284960 | ||||
| Other Study ID Numbers ICMJE | 18805, NIH: K24 H001476 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Penn State University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Penn State University | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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