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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1; Macroangiopathy
• Interventions: Device: Multispectral optoacoustic tomography; Diagnostic Test: Ankle Brachial Index; Diagnostic Test: Neuropathy Disability Score

• Registration Number: NCT05935839
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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).

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study Start: 2023-07-01
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 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

2. 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

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric Patients with diabetes mellitus type 1	Ankle Brachial Index	* 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)
Adult Patients with diabetes mellitus type 1	Neuropathy Disability Score	* 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)
Healthy volunteers	Neuropathy Disability Score	- Age 18-99 years
Adult Patients with diabetes mellitus type 1	Multispectral optoacoustic tomography	* 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)
Adult Patients with diabetes mellitus type 1	Ankle Brachial Index	* 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)
Pediatric Patients with diabetes mellitus type 1	Neuropathy Disability Score	* 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)
Healthy volunteers	Ankle Brachial Index	- Age 18-99 years
Pediatric Patients with diabetes mellitus type 1	Multispectral optoacoustic tomography	* 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)
Healthy volunteers	Multispectral optoacoustic tomography	- Age 18-99 years

Primary Outcome Measures

Name	Time	Method
Visualization of tissue changes in diabetic patients using MSOT.	12 months	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.