Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
Noninvasive Characterization of Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.

Conditions
-----------------
Diabetes Mellitus, Type 1, Macroangiopathy

Intervention / Treatment
-----------------
* Device: Multispectral optoacoustic tomography
* Diagnostic Test: Ankle Brachial Index
* Diagnostic Test: Neuropathy Disability Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus type 1 Laboratory-confirmed diagnosis of diabetes mellitus type 1 Age 18-99 years Disease duration of at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) Written informed consent patients with diabetes mellitus type 1 Laboratory-confirmed diagnosis of diabetes mellitus type 1 Age 6-17 years Duration of disease at least 5, better 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) Written informed consent Healthy subjects Age 18-99 years Written informed consent Exclusion Criteria: Pregnancy Nursing mothers Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry). Tattoo in the area of the examination Subcutaneous fat over 3 cm Lack of written consent Inability to perform sufficient (brief) physical exertion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult Patients with diabetes mellitus type 1<br>Laboratory-confirmed diagnosis of diabetes mellitus type 1 Age 18-99 years Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) | Device: Multispectral optoacoustic tomography<br>* Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.<br>Diagnostic Test: Ankle Brachial Index<br>* Dual measurement of ABI index before and after physical exercise.<br>Diagnostic Test: Neuropathy Disability Score<br>* Single measurement of the NSS<br>|
| Experimental: Pediatric Patients with diabetes mellitus type 1<br>Laboratory-confirmed diagnosis of diabetes mellitus type 1 Age 6-17 years Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) | Device: Multispectral optoacoustic tomography<br>* Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.<br>Diagnostic Test: Ankle Brachial Index<br>* Dual measurement of ABI index before and after physical exercise.<br>Diagnostic Test: Neuropathy Disability Score<br>* Single measurement of the NSS<br>|
| Experimental: Healthy volunteers<br>- Age 18-99 years | Device: Multispectral optoacoustic tomography<br>* Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.<br>Diagnostic Test: Ankle Brachial Index<br>* Dual measurement of ABI index before and after physical exercise.<br>Diagnostic Test: Neuropathy Disability Score<br>* Single measurement of the NSS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |