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

• Sponsor: University of Pavia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01049750
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Duration (Months): 61
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetic Patients; Erectile Dysfunction	Other: type 2 diabetic patients

Study Design

• Study Type: Observational
• Actual Enrollment: 220 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
type 2 diabetic patients males; type 2 diabetic patients	Other: type 2 diabetic patients; males; type 2 diabetic patients

Outcome Measures

Primary Outcome Measures

1. Prevalence of erectile dysfunction [Baseline (time 0); 3 months; 6 months]

2. Description of erectile disfunction markers [Baseline (time 0); 3 months; 6 months]

3. Evaluation of diabetic neuropathy in patients with erectile dysfunction [Baseline (time 0); 3 months; 6 months]

Secondary Outcome Measures

1. Metalloproteinases 2 and 9 [Baseline (time 0); 3 months; 6 months]

2. Insulin-sensitivity index (HOMA index) [Baseline (time 0); 3 months; 6 months]

3. Glycemic control [Baseline (time 0); 3 months; 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Matteo	Pavia		Italy	27100

Sponsors and Collaborators

• University of Pavia

Investigators

• Principal Investigator: Giuseppe Derosa, MD, PhD, University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Derosa, Professor, University of Pavia
• ClinicalTrials.gov Identifier: NCT01049750
• Other Study ID Numbers: 20090001127; P-20090002836
• First Posted: Jan 14, 2010
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Giuseppe Derosa, Professor, University of Pavia: type 2 diabetes mellitus; male; erectile dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Mar 17, 2015