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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01049750
Enrollment
220
Registered
2010-01-14
Start date
2009-06-30
Completion date
2014-07-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Type 2 Diabetic Patients

Keywords

type 2 diabetes mellitus, male, erectile dysfunction

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.

Interventions

OTHERtype 2 diabetic patients

males; type 2 diabetic patients

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of erectile dysfunctionBaseline (time 0); 3 months; 6 months
Description of erectile disfunction markersBaseline (time 0); 3 months; 6 months
Evaluation of diabetic neuropathy in patients with erectile dysfunctionBaseline (time 0); 3 months; 6 months

Secondary

MeasureTime frame
Metalloproteinases 2 and 9Baseline (time 0); 3 months; 6 months
Insulin-sensitivity index (HOMA index)Baseline (time 0); 3 months; 6 months
Glycemic controlBaseline (time 0); 3 months; 6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026