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

NCT ID: NCT01049750

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Type 2 Diabetic Patients Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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type 2 diabetic patients

males; type 2 diabetic patients

type 2 diabetic patients

Intervention Type OTHER

males; type 2 diabetic patients

Interventions

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type 2 diabetic patients

males; type 2 diabetic patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Derosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia

Locations

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IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 22572549 (View on PubMed)

Derosa 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.

Reference Type RESULT
PMID: 25747572 (View on PubMed)

Other Identifiers

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P-20090002836

Identifier Type: REGISTRY

Identifier Source: secondary_id

20090001127

Identifier Type: -

Identifier Source: org_study_id

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