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The objective of the proposed study is to assess gastric emptying time (GET) based on contrast-enhanced multispectral optoacoustic imaging (CE-MSOT) in a collective of patients with type 1 diabetes mellitus (T1DM). The results will be correlated with disease duration and severity.
T1DM is a chronic autoimmune disease in which autoantibodies destroy the pancreas's insulin-producing cells. In Germany, it is estimated that 32,000 children and adolescents and approximately 335,000 adults suffer from T1DM. The trend has been increasing in recent years.
A complication of T1DM is diabetic gastroparesis (DGP), in which gastric emptying is delayed without mechanical obstruction. Symptoms of DGP include nausea, vomiting, and abdominal pain. Many patients* are asymptomatic.
DGP is associated with higher HbA1c, autonomic neuropathy, nephropathy, retinopathy, and increased gastrointestinal symptoms.
In this study, gastric emptying will be imaged noninvasively and without radiation based on MSOT. MSOT, in addition to imaging endogenous chromophores, allows visualization of exogenous chromophores. If the dye indocyanine green (ICG) is ingested orally, the signal of the dye in the lumen of the gastrointestinal tract can be visualized noninvasively by MSOT over different intestinal segments. If food is labeled with ICG and ingested by subjects*, the passage of chyme through the gastrointestinal tract can be tracked by measuring the signal with MSOT, and transit times can be measured.
This study will investigate gastric emptying times of patients* with T1DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group 1 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy |
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| Study group 2 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy |
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| Study group 3 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged < 18 years, disease activity 5 - 10 years, HbA1c > 8,5% |
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| Study group 4 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged < 18 years, disease activity 5 - 10 years, HbA1c < 7,5% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT) | Device | Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying time | Gastric emptying time based on MSOT imaging of ICG-signal intensity | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of acquired hemoglobin signal with disease activity | Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity | 6 hours |
| Correlation of acquired hemoglobin signal with disease duration |
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nclusion criteria Group 1
Generality:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ferdinand Knieling | Contact | +4991318541151 | ferdinand.knieling@uk-erlangen.de | |
| Emmanuel Nedoschill | Contact | emmanuel.nedoschill@uk-erlangen.de |
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Four Arms with different disease activity and duration
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Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration |
| 6 hours |