Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
TRANSPARENT
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
July 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2023
CompletedJuly 7, 2023
June 1, 2023
5 months
June 28, 2023
June 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastric emptying time
Gastric emptying time based on MSOT imaging of ICG-signal intensity
6 hours
Secondary Outcomes (2)
Correlation of acquired hemoglobin signal with disease activity
6 hours
Correlation of acquired hemoglobin signal with disease duration
6 hours
Study Arms (4)
Study group 1
OTHERMultispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged\> 18 years, with diabetic neuropathy
Study group 2
OTHERMultispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged\> 18 years, without diabetic neuropathy
Study group 3
OTHERMultispectral 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%
Study group 4
OTHERMultispectral 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%
Interventions
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. Ferdinand Knieling
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 7, 2023
Study Start
July 15, 2023
Primary Completion
December 1, 2023
Study Completion
December 24, 2023
Last Updated
July 7, 2023
Record last verified: 2023-06