The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction

NCT ID: NCT00284960

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction Metabolic Syndrome Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-65 years of age, male,

Exclusion Criteria

* diabetes, peyronies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

J C Trussell, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hershey Med Center

Hershey, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH: K24 H001476

Identifier Type: -

Identifier Source: secondary_id

18805

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

DHS MIND Metabolomics
NCT03975309 COMPLETED