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

Primary Purpose

Diabetes Mellitus, Type 1, Macroangiopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multispectral optoacoustic tomography
Ankle Brachial Index
Neuropathy Disability Score
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1

Eligibility Criteria

6 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Adult Patients with diabetes mellitus type 1

    Pediatric Patients with diabetes mellitus type 1

    Healthy volunteers

    Arm Description

    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)

    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)

    - Age 18-99 years

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    June 28, 2023
    Sponsor
    University of Erlangen-Nürnberg Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05935839
    Brief Title
    Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.
    Official Title
    Noninvasive Characterization of Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Erlangen-Nürnberg Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1, Macroangiopathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adult Patients with diabetes mellitus type 1
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Pediatric Patients with diabetes mellitus type 1
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Healthy volunteers
    Arm Type
    Experimental
    Arm Description
    - Age 18-99 years
    Intervention Type
    Device
    Intervention Name(s)
    Multispectral optoacoustic tomography
    Intervention Description
    Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Ankle Brachial Index
    Intervention Description
    Dual measurement of ABI index before and after physical exercise.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Neuropathy Disability Score
    Intervention Description
    Single measurement of the NSS
    Primary Outcome Measure Information:
    Title
    Visualization of tissue changes in diabetic patients using MSOT.
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ferdinand Knieling, PD Dr. med.
    Phone
    +49 9131 85 41337
    Email
    ferdinand.knieling@uk-erlangen.de

    12. IPD Sharing Statement

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

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