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Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients (APGADEPD)

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ClinicalTrials.gov Identifier: NCT02770235
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin (AGEReaderTM).

If the hypothesis of an association between DE and AGE measured by AF was checked, screening for erectile dysfunction and measurement of AGEs could help to improve the overall management of diabetic patient (including cardiovascular) and their quality of life.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Erectile Dysfunction Other: DE assessment Other: AGE measurement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DE assessment and AGE measurements
To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
Other: DE assessment
by a validated self-administered questionnaire: Index International erectile function (IIEF-15)

Other: AGE measurement
By AGE-ReaderTM




Primary Outcome Measures :
  1. erectile dysfunction and AGE levels [ Time Frame: 2 hours ]
    To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Type 2

Exclusion Criteria:

  • skin hyperpigmentation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770235


Contacts
Contact: Youssef KOUIDRAT youssefpile@yahoo.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80000
Contact: Youssef KOUIDRAT       youssefpile@yahoo.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Youssef KOUIDRAT CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02770235     History of Changes
Other Study ID Numbers: PI2013_843_0021
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Erectile Dysfunction
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders