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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Erectile Dysfunction
• Interventions: Other: DE assessment; Other: AGE measurement

• Registration Number: NCT02770235
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-17
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2019-03-16
• Study Completion: 2019-03-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 97

Inclusion Criteria

• Diabetes Type 2

Exclusion Criteria

• skin hyperpigmentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DE assessment and AGE measurements	AGE measurement	To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
DE assessment and AGE measurements	DE assessment	To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France