Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic G… (NCT05935852) | Clinical Trial Compass
UnknownNot Applicable
Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
40 participantsStarted 2023-07-15
Plain-language summary
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.
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Gastric emptying time
Timeframe: 6 hours
Trial details
NCT IDNCT05935852
SponsorUniversity of Erlangen-Nürnberg Medical School