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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935839

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Macroangiopathy	Device: Multispectral optoacoustic tomography Diagnostic Test: Ankle Brachial Index Diagnostic Test: Neuropathy Disability Score	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adult Patients with diabetes mellitus type 1 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 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. Diagnostic Test: Neuropathy Disability Score Single measurement of the NSS
Experimental: Pediatric Patients with diabetes mellitus type 1 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 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. Diagnostic Test: Neuropathy Disability Score Single measurement of the NSS
Experimental: Healthy volunteers - Age 18-99 years	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. Diagnostic Test: Neuropathy Disability Score Single measurement of the NSS

Arm

Intervention/Treatment

Experimental: Adult Patients with diabetes mellitus type 1

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

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.

Diagnostic Test: Neuropathy Disability Score

Single measurement of the NSS

Experimental: Pediatric Patients with diabetes mellitus type 1

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

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.

Diagnostic Test: Neuropathy Disability Score

Single measurement of the NSS

Experimental: Healthy volunteers

- Age 18-99 years

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.

Diagnostic Test: Neuropathy Disability Score

Single measurement of the NSS

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT05935839

Other Study ID Numbers:

23-205-B

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 7, 2023