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

NCT ID: NCT02770235

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-17

Study Completion Date

2019-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

DE assessment

Intervention Type OTHER

by a validated self-administered questionnaire: Index International erectile function (IIEF-15)

AGE measurement

Intervention Type OTHER

By AGE-ReaderTM

Interventions

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DE assessment

by a validated self-administered questionnaire: Index International erectile function (IIEF-15)

Intervention Type OTHER

AGE measurement

By AGE-ReaderTM

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diabetes Type 2

Exclusion Criteria

* skin hyperpigmentation
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Daniel LALAU, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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Kouidrat Y, Zaitouni A, Amad A, Diouf M, Desailloud R, Loas G, Lalau JD. Skin autofluorescence (a marker for advanced glycation end products) and erectile dysfunction in diabetes. J Diabetes Complications. 2017 Jan;31(1):108-113. doi: 10.1016/j.jdiacomp.2016.10.026. Epub 2016 Oct 29.

Reference Type RESULT
PMID: 27847146 (View on PubMed)

Other Identifiers

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PI2013_843_0021

Identifier Type: -

Identifier Source: org_study_id

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