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

March 15, 2015 updated by: Giuseppe Derosa, University of Pavia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

males with type 2 diabetes mellitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
type 2 diabetic patients
males; type 2 diabetic patients
Other: type 2 diabetic patients
males; type 2 diabetic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of erectile dysfunction
Time Frame: Baseline (time 0); 3 months; 6 months
Baseline (time 0); 3 months; 6 months
Description of erectile disfunction markers
Time Frame: Baseline (time 0); 3 months; 6 months
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
Baseline (time 0); 3 months; 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Metalloproteinases 2 and 9
Time Frame: Baseline (time 0); 3 months; 6 months
Baseline (time 0); 3 months; 6 months
Insulin-sensitivity index (HOMA index)
Time Frame: Baseline (time 0); 3 months; 6 months
Baseline (time 0); 3 months; 6 months
Glycemic control
Time Frame: Baseline (time 0); 3 months; 6 months
Baseline (time 0); 3 months; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 15, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090001127
  • P-20090002836 (Registry Identifier: 20090002304)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on type 2 diabetic patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe