A new non-invasive method to assess cardiovascular risks in type 2 diabetic patients and the correlation to treatment types
| ISRCTN | ISRCTN50136555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50136555 |
| Secondary identifying numbers | GS1-EK-2/463-2019 |
- Submission date
- 25/08/2020
- Registration date
- 25/10/2020
- Last edited
- 01/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Advanced glycation end products (AGEs) have been identified to play a major role in diabetic complications. They are elevated at high blood sugar concentrations, accumulate slowly throughout the lifespan and contribute to changes in the cardiovascular system (heart and blood vessels). Non-invasive measurement of skin autofluorescence (SAF) estimates the skin tissue AGE content and is able to predict cardiovascular complications, at least in certain patients, which could be used in daily clinical practice. The AGE Reader is a non-invasive monitoring device that uses ultraviolet light. The measurement of AGEs provides an immediate cardiovascular risk prediction within 20 seconds. The AGE Reader has been designed for patient-friendly diagnosis, and because of this allows doctors to practice personalized care and prevent disease (progression). Additionally, the method is convenient, easy to use, and extensively tested. The aim of this study is to assess cardiovascular risks using the non-invasive measurement of skin accumulation of AGEs.
Who can participate?
Type 2 diabetic patients between 18-70 years old and without skin diseases
What does the study involve?
The study involves the assessment of AGEs in the skin and correlation to cardiovascular risks. This study also examines the effect of different diabetic treatments on the accumulation of the AGEs in the body.
What are the possible benefits and risks of participating?
Early diagnosis of cardiovascular risk factors using a non-invasive technique in clinical practice.
Where is the study run from?
Melk Hospital (Austria)
When is the study starting and how long is it expected to run for?
February 2019 to February 2021
Who is funding the study?
Melk Hospital (Austria)
Who is the main contact?
Dr Nawras Al-Taie
Nawras.altaie@reflex.at
Contact information
Scientific
Melk Diabetes Center
Melk
3390
Austria
 ORCID ID |
0000-0003-0522-4583 |
|---|---|
| Phone | +43 (0)2752/9004-0 |
| nawras.altaie@reflex.at |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN50136555_PIS_V4.docx |
| Scientific title | Assessing the accumulation of advanced glycation end products among patients with type 2 diabetes |
| Study objectives | This is a pilot study to assess the accumulation of AGEs molecules among patients with type 2 diabetes in different treatments groups as part of the cardiovascular risk evaluation. |
| Ethics approval(s) | Approved 26/11/2019, NÖ Ethikkommission (Ethikkommission Für Das Bundesland Niederösterreich Am Sitz Des Amtes Der Nö Landesregierung, Gruppe Gesundheit und Soziales - Abteilung Sanitätsdirektion, 3109 St. Pölten, Landhausplatz 1, Austria; +43 (0)2742/9005-9005; post.ethikkommission@noel.gv.at), ref: GS4-EK-2/463-2019 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | AGEs (advanced glycation end-products) are measured using the non-invasive measurement of skin autofluorescence (SAF), which estimates the skin tissue AGEs content and thus may predict cardiovascular complications. The researchers are planning a follow up to 6 months after the first measurement. |
| Intervention type | Other |
| Primary outcome measure | AGEs accumulation measured using skin autofluorescence at 3, 6 and 12 months |
| Secondary outcome measures | The effect of various treatment types of type 2 diabetes on the accumulation of AGEs measured using skin autofluorescence at 3, 6 and 12 months |
| Overall study start date | 01/02/2019 |
| Completion date | 01/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | 1. Type 2 diabetic patients 2. Aged between 18 and 70 years 3. Moderate to high cardiovascular risk factors 4. Routinely attend the diabetes outpatients service of the Department of Internal Medicine in the Hospital of Melk 5. Patients will be included independently of their medication |
| Key exclusion criteria | Patients with dark skin, patients with skin diseases and the use of skin creams, such as agents used to “tan” or “brown” the skin, cannot be included in the study because of limitations to the autofluorescence measurement, which is adjusted to healthy white skin and may give inadequate results in dark skin. |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 01/11/2021 |
Locations
Countries of recruitment
- Austria
Study participating centre
3390
Austria
Sponsor information
Hospital/treatment centre
Melk Diabetes Center
Krankenhausstraße 11
3390 Melk
Melk
3390
Austria
| Phone | +43 (0)2752/9004-0 |
|---|---|
| nawras.altaie@reflex.at | |
| Website | https://melk.lknoe.at |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nawras Al-Taie (Nawras.altaie@reflex.at). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V4 | 06/11/2020 | No | Yes |
Additional files
- ISRCTN50136555_PIS_V4.docx
- uploaded 06/11/2020
Editorial Notes
01/03/2021: Internal review.
06/11/2020: The participant information sheet was uploaded as an additional file.
07/09/2020: Trial's existence confirmed by NÖ Ethikkommission.
