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OpenTrials
Completed

NCT Number: NCT01049750

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

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.

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Key information

Conditions

Type 2 Diabetic Patients Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

type 2 diabetic patients

Other

males; type 2 diabetic patients

Primary outcomes

  1. Prevalence of erectile dysfunction

    Time frame: Baseline (time 0); 3 months; 6 months

  2. Description of erectile disfunction markers

    Time frame: Baseline (time 0); 3 months; 6 months

  3. Evaluation of diabetic neuropathy in patients with erectile dysfunction

    Time frame: Baseline (time 0); 3 months; 6 months

Secondary outcomes

  1. Metalloproteinases 2 and 9

    Time frame: Baseline (time 0); 3 months; 6 months

  2. Insulin-sensitivity index (HOMA index)

    Time frame: Baseline (time 0); 3 months; 6 months

  3. Glycemic control

    Time frame: Baseline (time 0); 3 months; 6 months

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2010
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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