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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935839
• Other study ID #: 23-205-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Ferdinand Knieling, PD Dr. med.
• Phone: +49 9131 85 41337
• Email: ferdinand.knieling[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Macroangiopathy

Intervention

Device:
• Multispectral optoacoustic tomography
Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.

Diagnostic Test:
• Ankle Brachial Index
Dual measurement of ABI index before and after physical exercise.
• Neuropathy Disability Score
Single measurement of the NSS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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