Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis (TRANSPARENT)
Diabetic Gastroparesis
About this trial
This is an interventional diagnostic trial for Diabetic Gastroparesis focused on measuring diabetic gastroparesis, MSOT
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Study group 1
Study group 2
Study group 3
Study group 4
Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy
Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy
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%
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%