Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
2 other identifiers
observational
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 17, 2015
March 1, 2015
5.1 years
January 11, 2010
March 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prevalence of erectile dysfunction
Baseline (time 0); 3 months; 6 months
Description of erectile disfunction markers
Baseline (time 0); 3 months; 6 months
Evaluation of diabetic neuropathy in patients with erectile dysfunction
Baseline (time 0); 3 months; 6 months
Secondary Outcomes (3)
Metalloproteinases 2 and 9
Baseline (time 0); 3 months; 6 months
Insulin-sensitivity index (HOMA index)
Baseline (time 0); 3 months; 6 months
Glycemic control
Baseline (time 0); 3 months; 6 months
Study Arms (1)
type 2 diabetic patients
males; type 2 diabetic patients
Interventions
Eligibility Criteria
males with type 2 diabetes mellitus
You may qualify if:
- type 2 diabetes mellitus
You may not qualify if:
- type 1 diabetes mellitus
- \< 18 years old
- anatomic abnormalities of the penis
- patients taking erectile dysfunction therapy at the moment of the enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Related Publications (2)
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;59(7):611-9. doi: 10.1507/endocrj.ej12-0117. Epub 2012 May 26.
PMID: 22572549RESULTDerosa G, Romano D, Tinelli C, D'Angelo A, Maffioli P. Prevalence and associations of erectile dysfunction in a sample of Italian males with type 2 diabetes. Diabetes Res Clin Pract. 2015 May;108(2):329-35. doi: 10.1016/j.diabres.2015.01.037. Epub 2015 Feb 7.
PMID: 25747572RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Derosa, MD, PhD
University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 14, 2010
Study Start
June 1, 2009
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03