Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by University of Pavia.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Pavia

ClinicalTrials.gov Identifier:

NCT01049750

First received: January 11, 2010

Last updated: January 14, 2010

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2010

Last Updated Date

January 14, 2010

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prevalence of erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
Description of erectile disfunction markers [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
Evaluation of diabetic neuropathy in patients with erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Prevalence of erectile dysfunction; description of erectile disfunction markers; evaluation of association among erectile dysfunction-endothelial damage-atherosclerotic status; evaluation between diabetic neuropathy and erectile dysfunction [ Time Frame: at the moment of the enrollment ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01049750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metalloproteinases 2 and 9 [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
Insulin-sensitivity index (HOMA index) [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
Glycemic control [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Evaluation of the association between erectile dysfunction and metalloproteinases; and insulin-sensitivity index (HOMA index); and glycemic control [ Time Frame: at the moment of the enrollment ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

Official Title ^ICMJE

Not Provided

Brief 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. 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

males with type 2 diabetes mellitus

Condition ^ICMJE

Type 2 Diabetic Patients
Erectile Dysfunction

Intervention ^ICMJE

Other: type 2 diabetic patients

males; type 2 diabetic patients

Study Group/Cohort (s)

type 2 diabetic patients

males; type 2 diabetic patients

Intervention: Other: type 2 diabetic patients

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

February 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

type 2 diabetes mellitus

Exclusion Criteria:

type 1 diabetes mellitus
< 18 years old
anatomic abnormalities of the penis
patients taking erectile dysfunction therapy at the moment of the enrollment

Gender

Male

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01049750

Other Study ID Numbers ^ICMJE

20090001127, P-20090002836

Has Data Monitoring Committee

Yes

Responsible Party

Giuseppe Derosa, University of Pavia

Study Sponsor ^ICMJE

University of Pavia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Giuseppe Derosa, MD, PhD

University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia

Information Provided By

University of Pavia

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top