Erectile DysfunctionNCT00284960
The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
An observational study of Erectile Dysfunction and Metabolic Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Metabolic Syndrome, Insulin Resistance
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age, male,
Who cannot join
- diabetes, peyronies
Trial locations and contacts
1 site in 1 country.
About this study
Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.
Read the 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.
- Conditions
- Erectile Dysfunction, Metabolic Syndrome, Insulin Resistance
- Keywords
- erectile dysfunction, metabolic syndrome, insulin resistance, etiology
- Medical subject headings
- Erectile Dysfunction, Metabolic Syndrome, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJun 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J C Trussell, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284960
- Sponsor's protocol ID
- 18805
- Other IDs
- NIH: K24 H001476
- Status last verified
- Aug 2017
- First submitted
- 31 Jan 2006
- Last updated
- 3 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00284960
- Acronym / sponsor ID
- 18805
- Conditions
- Erectile Dysfunction, Metabolic Syndrome, Insulin Resistance
- Keywords
- erectile dysfunction, metabolic syndrome, insulin resistance, etiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years of age, male,
Key exclusion criteria (1 listed)
- diabetes, peyronies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J C Trussell, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Metabolic Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.