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NCT00134329 Clinical Trial

Erectile Dysfunction and Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Erectile Dysfunction and Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00134329
Other study ID # 2005/096
Secondary ID
Status Completed
Phase N/A
First received August 23, 2005
Last updated December 19, 2007
Start date May 2005
Est. completion date March 2007

Study information
Verified date December 2007
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study consists of filling out a questionnaire on possible erectile dysfunction.

Description:

Male diabetic patients who attend a diabetic routine year program visit will be asked to give their voluntary permission to fill out a questionnaire on possible erectile dysfunction.

The questionnaire consists of two parts: Part 1 is the IIEF (International Index of Erectile Function) questionnaire and Part 2 is an additional questionnaire. The included patients have to fill out these questionnaires two times; once at the beginning at a diabetic year program visit and a second time one year later at the next diabetic year program consultation.

The patients will also be asked to give their permission for using their results of the routine diabetic year program for scientific research.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male diabetic patients

- Age older than 18 years

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Filling out a questionnaire on the possible occurrence of erectile dysfunction

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Documentation of the prevalence of erectile dysfunction in the diabetic convention
Primary Increase the awareness of diabetologist for erectile dysfunction
Primary Relation of erectile dysfunction with metabolic parameters
Primary Relation of erectile dysfunction with sex steroids
Secondary Adjustment of the systematic follow-up of diabetic complications.
Secondary Optimalisation of the healthcare for diabetic patients, so that the quality of life for male diabetic patients can be improved
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