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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University of Pavia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pavia
ClinicalTrials.gov Identifier:
NCT01049750
First received: January 11, 2010
Last updated: January 14, 2010
Last verified: June 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 250
Study Start Date: June 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049750

Locations
Italy
University of Pavia - Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Giuseppe Derosa
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
  More Information

No publications provided

Responsible Party: Giuseppe Derosa, University of Pavia
ClinicalTrials.gov Identifier: NCT01049750     History of Changes
Other Study ID Numbers: 20090001127, P-20090002836
Study First Received: January 11, 2010
Last Updated: January 14, 2010
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013