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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by Penn State University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00284960
First received: January 31, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose
Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.

Condition Phase
Erectile Dysfunction Metabolic Syndrome Insulin Resistance Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Incidence and Treatment of Insulin Resistance Among Men With Erectile

Resource links provided by NLM:


Further study details as provided by Penn State University:

Estimated Enrollment: 30
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age, male,

Exclusion Criteria:

  • diabetes, peyronies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284960

Contacts
Contact: Sue Worley, RN 717-531-5718 sworley@psu.edu

Locations
United States, Pennsylvania
Hershey Med Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sue Worley, RN    717-531-5718    sworley@psu.edu   
Contact: Danielle Schreiner    717-531-8848 ext 3    dschreiner@psu.edu   
Sub-Investigator: Richard Legro, MD         
Sub-Investigator: Lawrence Sinoway, MD         
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: J C Trussell, MD
  More Information

ClinicalTrials.gov Identifier: NCT00284960     History of Changes
Other Study ID Numbers: 18805
NIH: K24 H001476
Study First Received: January 31, 2006
Last Updated: January 31, 2006

Keywords provided by Penn State University:
erectile dysfunction
metabolic syndrome
insulin resistance
etiology

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Erectile Dysfunction
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017