Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Device: Multispectral Optoacoustic Tomography (MSOT)


Participation Criteria
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Eligibility Criteria
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nclusion criteria Group 1 Written informed consent T1DM diagnosis Duration of disease at least 5, preferably 10 years with diagnosed neuropathy Group 2 Written informed consent T1DM diagnosis Duration of disease at least 5, preferably 10 years without diagnosed neuropathy Group 3 Written informed consent from parent or guardian T1DM diagnosis Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/l) Group 4 Written informed consent of parent or guardian T1DM diagnosis Duration of disease at least 5, preferably 10 years with good medication control (HbA1c value < 7.5 mmol/l) Exclusion criteria Generality: Pregnancy Breastfeeding mothers Tattoo in the area of the examination Subcutaneous fat tissue over 3 cm Known hypersensitivity to ICG, sodium iodide or iodine Hyperthyroidism, focal or diffuse thyroid autonomy Timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study) Impaired renal function Taking the following medications: Beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Four Arms with different disease activity and duration
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study group 1<br>Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses<br>|
| Other: Study group 2<br>Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses<br>|
| Other: Study group 3<br>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% | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses<br>|
| Other: Study group 4<br>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% | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | Gastric emptying time based on MSOT imaging of ICG-signal intensity | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic gastroparesis, MSOT