NCT02770235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2019

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

May 11, 2016

Last Update Submit

September 16, 2025

Conditions

Diabetes Mellitus, Non-Insulin-DependentErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

DE assessment and AGE measurements

EXPERIMENTAL

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

Other: DE assessmentOther: AGE measurement

Interventions

DE assessmentOTHER

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

DE assessment and AGE measurements
AGE measurementOTHER

By AGE-ReaderTM

DE assessment and AGE measurements

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes Type 2

You may not qualify if:

  • skin hyperpigmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

Related Publications (1)

  • 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.

    PMID: 27847146RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Erectile Dysfunction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Jean-Daniel LALAU, MD PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 12, 2016

Study Start

March 17, 2014

Primary Completion

March 16, 2019

Study Completion

March 16, 2019

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)