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In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.
After informing the patients and parents/guardians and checking the inclusion and exclusion criteria, the clinical data of the ill subjects are recorded and the HbA1c is measured in the laboratory as part of the routine recording. The blood collection is part of the routine diagnostics on presentation in the outpatient clinic and is performed separately from the study.
Subsequently, imaging by MSOT is performed in all study participants. This is performed on both sides of the lower leg over the triceps surae muscle. The examination is analogous to sonography over the corresponding skin layers without further invasive procedures. The anatomical region can be localized by means of built-in sonography; subsequently, the corresponding optoacoustic signals can be derived over it. This is followed by measurement of the Arm-Brachial-Index. After a short recovery time, the test persons perform a physical stress on the examined lower leg muscles. After renewed ABI measurement, the imaging examination is repeated using MSOT. Finally, the neurological status is assessed using the Neuropathy Disability Score (NSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Patients with diabetes mellitus type 1 | Experimental |
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| Pediatric Patients with diabetes mellitus type 1 | Experimental |
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| Healthy volunteers | Experimental | - Age 18-99 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multispectral optoacoustic tomography | Device | Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visualization of tissue changes in diabetic patients using MSOT. | Comparison of the quantitative percentage of oxygenated/deoxygenated hemoglobin determined by MSOT in adults and children with diabetes mellitus and an adult healthy control group. | 12 months |
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Inclusion Criteria:
Patients with diabetes mellitus type 1
patients with diabetes mellitus type 1
Healthy subjects
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ferdinand Knieling, PD Dr. med. | Contact | +49 9131 85 41337 | ferdinand.knieling@uk-erlangen.de |
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| Ankle Brachial Index | Diagnostic Test | Dual measurement of ABI index before and after physical exercise. |
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| Neuropathy Disability Score | Diagnostic Test | Single measurement of the NSS |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D055109 | Ankle Brachial Index |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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