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NCT02770235 Clinical Trial

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

Erectile Dysfunction Clinical Trial

— APGADEPD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02770235
Other study ID # PI2013_843_0021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2014
Est. completion date March 16, 2019

Study information
Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date March 16, 2019
Est. primary completion date March 16, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diabetes Type 2

Exclusion Criteria:

- skin hyperpigmentation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• DE assessment
by a validated self-administered questionnaire: Index International erectile function (IIEF-15)
• AGE measurement
By AGE-ReaderTM

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary erectile dysfunction and AGE levels To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients 2 hours
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