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

Erectile Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049750
• Other study ID #: 20090001127
• Secondary ID: P-20090002836
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: March 15, 2015
• Start date: June 2009
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Erectile Dysfunction
• Type 2 Diabetic Patients

Intervention

Other:
• type 2 diabetic patients
males; type 2 diabetic patients

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 Fe — View Citation

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. Epub 2012 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of erectile dysfunction		Baseline (time 0); 3 months; 6 months	Yes
Primary	Description of erectile disfunction markers		Baseline (time 0); 3 months; 6 months	Yes
Primary	Evaluation of diabetic neuropathy in patients with erectile dysfunction		Baseline (time 0); 3 months; 6 months	Yes
Secondary	Metalloproteinases 2 and 9		Baseline (time 0); 3 months; 6 months	Yes
Secondary	Insulin-sensitivity index (HOMA index)		Baseline (time 0); 3 months; 6 months	Yes
Secondary	Glycemic control		Baseline (time 0); 3 months; 6 months	Yes