NCT01049750|CompletedDMC
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Sponsor study identifier
Secondary identifiers
REGISTRY · 20090002304
observational
220
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2010
Actual (reported)January 14, 2010
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)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
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
males; type 2 diabetic patients
males; type 2 diabetic patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
males with type 2 diabetes mellitus
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
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.
Derosa 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.
Giuseppe Derosa, MD, PhD
University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
220 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2010
First Posted
January 14, 2010
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
March 17, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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