Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
Completed
- Conditions
- Type 2 Diabetic PatientsErectile Dysfunction
- Interventions
- Other: type 2 diabetic patients
- Registration Number
- NCT01049750
- Lead Sponsor
- University of Pavia
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 220
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description type 2 diabetic patients type 2 diabetic patients males; type 2 diabetic patients
- Primary Outcome Measures
Name Time Method Prevalence of erectile dysfunction Baseline (time 0); 3 months; 6 months Evaluation of diabetic neuropathy in patients with erectile dysfunction Baseline (time 0); 3 months; 6 months Description of erectile disfunction markers Baseline (time 0); 3 months; 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy