Type 2 Diabetic PatientsNCT01049750
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
An observational study of Type 2 Diabetic Patients and Erectile Dysfunction, run by University of Pavia at 1 site in Italy.
Trial summary
The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Type 2 Diabetic Patients, Erectile Dysfunction
- What is being tested?
- type 2 diabetic patients
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Jul 2014
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: males with type 2 diabetes mellitus
Who may be able to join
- type 2 diabetes mellitus
Who cannot join
- type 1 diabetes mellitus
- < 18 years old
- anatomic abnormalities of the penis
- patients taking erectile dysfunction therapy at the moment of the enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.
- Conditions
- Type 2 Diabetic Patients, Erectile Dysfunction
- Being tested
- type 2 diabetic patients
- Keywords
- type 2 diabetes mellitus, male, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type 2 diabetic patientsOther
males; type 2 diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetic patients | males; type 2 diabetic patients Receives: Other: type 2 diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of erectile dysfunction
Measured: Baseline (time 0); 3 months; 6 months
Description of erectile disfunction markers
Measured: Baseline (time 0); 3 months; 6 months
Evaluation of diabetic neuropathy in patients with erectile dysfunction
Measured: Baseline (time 0); 3 months; 6 months
Secondary outcomes (3)
Metalloproteinases 2 and 9
Measured: Baseline (time 0); 3 months; 6 months
Insulin-sensitivity index (HOMA index)
Measured: Baseline (time 0); 3 months; 6 months
Glycemic control
Measured: Baseline (time 0); 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetic PatientsStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, Principal investigator, University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049750
- Sponsor's protocol ID
- 20090001127
- Other IDs
- P-20090002836
- Status last verified
- Mar 2015
- First submitted
- 11 Jan 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Derosa G, Tinelli C, D'Angelo A, Ferrara G, Bonaventura A, Bianchi L, Romano D, Fogari E, Maffioli P. Glyco-metabolic profile among type 2 diabetic patients with erectile dysfunction. Endocr J. 2012;59(7):611-9. doi: 10.1507/endocrj.ej12-0117. Epub 2012 May 26.
PubMed 22572549Derosa G, Romano D, Tinelli C, D'Angelo A, Maffioli P. Prevalence and associations of erectile dysfunction in a sample of Italian males with type 2 diabetes. Diabetes Res Clin Pract. 2015 May;108(2):329-35. doi: 10.1016/j.diabres.2015.01.037. Epub 2015 Feb 7.
PubMed 25747572
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01049750
- Acronym / sponsor ID
- 20090001127
- Conditions
- Type 2 Diabetic Patients, Erectile Dysfunction
- Keywords
- type 2 diabetes mellitus, male, erectile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Jan 2010 (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.
The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetic patients | – | Other: type 2 diabetic patientsmales; type 2 diabetic patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- males with type 2 diabetes mellitus
Key inclusion criteria (1 listed)
- type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- type 1 diabetes mellitus
- < 18 years old
- anatomic abnormalities of the penis
- patients taking erectile dysfunction therapy at the moment of the enrollment
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 |
|---|---|---|
| type 2 diabetic patientsmales; type 2 diabetic patients | Other | type 2 diabetic patients |
Primary outcome
Prevalence of erectile dysfunction
Time frame: Baseline (time 0); 3 months; 6 months
Description of erectile disfunction markers
Time frame: Baseline (time 0); 3 months; 6 months
Evaluation of diabetic neuropathy in patients with erectile dysfunction
Time frame: Baseline (time 0); 3 months; 6 months
3 secondary outcomes
Metalloproteinases 2 and 9
Time frame: Baseline (time 0); 3 months; 6 months
Insulin-sensitivity index (HOMA index)
Time frame: Baseline (time 0); 3 months; 6 months
Glycemic control
Time frame: Baseline (time 0); 3 months; 6 months
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 17 Mar 2015.
- Results publication: PubMed 22572549Derosa G, Tinelli C, D'Angelo A, Ferrara G, Bonaventura A, Bianchi L, Romano D, Fogari E, Maffioli P. Glyco-metabolic profile among type 2 diabetic patients with erectile dysfunction. Endocr J. 2012;59(7):611-9. doi: 10.1507/endocrj.ej12-0117. Epub 2012 May 26.
- Results publication: PubMed 25747572Derosa G, Romano D, Tinelli C, D'Angelo A, Maffioli P. Prevalence and associations of erectile dysfunction in a sample of Italian males with type 2 diabetes. Diabetes Res Clin Pract. 2015 May;108(2):329-35. doi: 10.1016/j.diabres.2015.01.037. Epub 2015 Feb 7.
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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.
Giuseppe Derosa, MD, PhD principal investigator
University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
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 Type 2 Diabetic Patients and Erectile Dysfunction, run by University of Pavia at 1 site in Italy.
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 4 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 17 Mar 2015. 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 Italy. 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?
Prevalence of erectile dysfunction (time frame: Baseline (time 0); 3 months; 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049750, which also lists 2 linked publications.
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 17 Mar 2015.