Diabetes MellitusNCT00134329
Erectile Dysfunction and Diabetes Mellitus
An observational study of Diabetes Mellitus and Erectile Dysfunction, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study consists of filling out a questionnaire on possible erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Erectile Dysfunction
- What is being tested?
- Filling out a questionnaire on the possible occurrence of erectile dysfunction
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- May 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male diabetic patients
- Age older than 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study consists of filling out a questionnaire on possible erectile dysfunction.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Erectile Dysfunction
- Being tested
- Filling out a questionnaire on the possible occurrence of erectile dysfunction
- Medical subject headings
- Diabetes Mellitus, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling out a questionnaire on the possible occurrence of erectile dysfunctionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of the prevalence of erectile dysfunction in the diabetic convention
Increase the awareness of diabetologist for erectile dysfunction
Relation of erectile dysfunction with metabolic parameters
Relation of erectile dysfunction with sex steroids
Secondary outcomes (2)
Adjustment of the systematic follow-up of diabetic complications.
Optimalisation of the healthcare for diabetic patients, so that the quality of life for male diabetic patients can be improved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startMay 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 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Guy T'Sjoen, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134329
- Sponsor's protocol ID
- 2005/096
- Status last verified
- Dec 2007
- First submitted
- 23 Aug 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00134329
- Acronym / sponsor ID
- 2005/096
- Conditions
- Diabetes Mellitus, Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Aug 2005 (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.
This study consists of filling out a questionnaire on possible erectile dysfunction.
Detailed 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male diabetic patients
- Age older than 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling out a questionnaire on the possible occurrence of erectile dysfunction | Procedure or surgery | – |
Primary outcome
Documentation of the prevalence of erectile dysfunction in the diabetic convention
Increase the awareness of diabetologist for erectile dysfunction
Relation of erectile dysfunction with metabolic parameters
Relation of erectile dysfunction with sex steroids
2 secondary outcomes
Adjustment of the systematic follow-up of diabetic complications.
Optimalisation of the healthcare for diabetic patients, so that the quality of life for male diabetic patients can be improved
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 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Guy T'Sjoen, MD principal investigator
University Hospital, Ghent
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 Diabetes Mellitus and Erectile Dysfunction, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 0 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 28 Dec 2007. 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 Belgium. 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.
What does the primary outcome measure?
Documentation of the prevalence of erectile dysfunction in the diabetic convention. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 Dec 2007; AzTrials last refreshed its copy on 27 Oct 2026.