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

June 28, 2023 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of tissue changes in diabetic patients using MSOT.
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-205-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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