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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia
ClinicalTrials.gov Identifier:
NCT01049750
First received: January 11, 2010
Last updated: August 18, 2013
Last verified: August 2013

January 11, 2010
August 18, 2013
June 2009
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Prevalence of erectile dysfunction; description of erectile disfunction markers; evaluation of association among erectile dysfunction-endothelial damage-atherosclerotic status; evaluation between diabetic neuropathy and erectile dysfunction [ Time Frame: at the moment of the enrollment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01049750 on ClinicalTrials.gov Archive Site
  • 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 ]
Evaluation of the association between erectile dysfunction and metalloproteinases; and insulin-sensitivity index (HOMA index); and glycemic control [ Time Frame: at the moment of the enrollment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

males with type 2 diabetes mellitus

  • Type 2 Diabetic Patients
  • Erectile Dysfunction
Other: type 2 diabetic patients
males; type 2 diabetic patients
type 2 diabetic patients
males; type 2 diabetic patients
Intervention: Other: type 2 diabetic patients
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 Jul 31;59(7):611-9. Epub 2012 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01049750
20090001127, P-20090002836
Yes
Giuseppe Derosa, University of Pavia
University of Pavia
Not Provided
Principal Investigator: Giuseppe Derosa, MD, PhD University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
University of Pavia
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP