Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients (APGADEPD)
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent, Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DE assessment
AGE measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Non-Insulin-Dependent
Eligibility Criteria
Inclusion Criteria:
- Diabetes Type 2
Exclusion Criteria:
- skin hyperpigmentation
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DE assessment and AGE measurements
Arm Description
To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02770235
First Posted
May 11, 2016
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02770235
Brief Title
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Acronym
APGADEPD
Official Title
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 17, 2014 (Actual)
Primary Completion Date
March 16, 2019 (Actual)
Study Completion Date
March 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent, Erectile Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE assessment and AGE measurements
Arm Type
Experimental
Arm Description
To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
Intervention Type
Other
Intervention Name(s)
DE assessment
Intervention Description
by a validated self-administered questionnaire: Index International erectile function (IIEF-15)
Intervention Type
Other
Intervention Name(s)
AGE measurement
Intervention Description
By AGE-ReaderTM
Primary Outcome Measure Information:
Title
erectile dysfunction and AGE levels
Description
To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes Type 2
Exclusion Criteria:
skin hyperpigmentation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Daniel LALAU, MD PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
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