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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT02770235

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

N/A

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

Actual Study Start Date :

Mar 17, 2014

Actual Primary Completion Date :

Mar 16, 2019

Actual Study Completion Date :

Mar 16, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

erectile dysfunction and AGE levels [2 hours]
To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Diabetes Type 2

Exclusion Criteria:

skin hyperpigmentation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80000

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Jean-Daniel LALAU, MD PhD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT02770235

Other Study ID Numbers:

PI2013_843_0021

First Posted:

May 12, 2016

Last Update Posted:

Jul 20, 2020

Last Verified:

Jul 1, 2020

Additional relevant MeSH terms:

Erectile Dysfunction

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 20, 2020