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

This study has been completed.
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia Identifier:
First received: January 11, 2010
Last updated: March 15, 2015
Last verified: March 2015
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 Intervention
Type 2 Diabetic Patients
Erectile Dysfunction
Other: type 2 diabetic patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

Further study details as provided by University of Pavia:

Primary Outcome Measures:
  • Prevalence of erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
  • Description of erectile disfunction markers [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
  • Evaluation of diabetic neuropathy in patients with erectile dysfunction [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Metalloproteinases 2 and 9 [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
  • Insulin-sensitivity index (HOMA index) [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]
  • Glycemic control [ Time Frame: Baseline (time 0); 3 months; 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: June 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
type 2 diabetic patients
males; type 2 diabetic patients
Other: type 2 diabetic patients
males; type 2 diabetic patients


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
males with type 2 diabetes mellitus

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01049750

IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
University of Pavia
Principal Investigator: Giuseppe Derosa, MD, PhD University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
  More Information

Responsible Party: Giuseppe Derosa, Professor, University of Pavia Identifier: NCT01049750     History of Changes
Other Study ID Numbers: 20090001127  P-20090002836 
Study First Received: January 11, 2010
Last Updated: March 15, 2015
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Pavia:
type 2 diabetes mellitus
erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological processed this record on May 26, 2016