Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
- Conditions
- Diabetic Gastroparesis
- Registration Number
- NCT05935852
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gastric emptying time 6 hours Gastric emptying time based on MSOT imaging of ICG-signal intensity
- Secondary Outcome Measures
Name Time Method Correlation of acquired hemoglobin signal with disease activity 6 hours Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity
Correlation of acquired hemoglobin signal with disease duration 6 hours Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration