Diabetes Mellitus, Type 1 Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
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 |
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