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Clinical Trials/NCT01049750
NCT01049750
Completed
Not Applicable

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

University of Pavia1 site in 1 country220 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetic Patients
Sponsor
University of Pavia
Enrollment
220
Locations
1
Primary Endpoint
Prevalence of erectile dysfunction
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
July 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Giuseppe Derosa

Professor

University of Pavia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of erectile dysfunction

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

Description of erectile disfunction markers

Time Frame: Baseline (time 0); 3 months; 6 months

Secondary Outcomes

  • Metalloproteinases 2 and 9(Baseline (time 0); 3 months; 6 months)
  • Insulin-sensitivity index (HOMA index)(Baseline (time 0); 3 months; 6 months)
  • Glycemic control(Baseline (time 0); 3 months; 6 months)

Study Sites (1)

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