Diabetes Mellitus, Non-Insulin-DependentAPGADEPDNCT02770235
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
A study testing DE assessment and AGE measurement in people with Diabetes Mellitus, Non-Insulin-Dependent and Erectile Dysfunction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent, Erectile Dysfunction
- What is being tested?
- DE assessment and AGE measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2014to 16 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Type 2
Who cannot join
- skin hyperpigmentation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- DE assessment, AGE measurement
- Medical subject headings
- Diabetes Mellitus, Type 2, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE assessmentOther
by a validated self-administered questionnaire: Index International erectile function (IIEF-15)
AGE measurementOther
By AGE-ReaderTM
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: DE assessment; Other: AGE measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start17 Mar 2014
- Primary completion16 Mar 2019
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Daniel LALAU, MD PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770235
- Sponsor's protocol ID
- PI2013_843_0021
- Acronym
- APGADEPD
- Status last verified
- Sep 2025
- First submitted
- 11 May 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27847146
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02770235
- Acronym / sponsor ID
- APGADEPD / PI2013_843_0021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DE assessment and AGE measurements | Experimental | Other: DE assessment, Other: AGE measurementTo evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes Type 2
Key exclusion criteria (1 listed)
- skin hyperpigmentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DE assessmentby a validated self-administered questionnaire: Index International erectile function (IIEF-15) | Other | DE assessment and AGE measurements |
| AGE measurementBy AGE-ReaderTM | Other | DE assessment and AGE measurements |
Primary outcome
erectile dysfunction and AGE levels
Time frame: 2 hours
To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 27847146Kouidrat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Daniel LALAU, MD PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DE assessment and AGE measurement in people with Diabetes Mellitus, Non-Insulin-Dependent and Erectile Dysfunction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
erectile dysfunction and AGE levels (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.