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

Primary Purpose

Diabetic Gastroparesis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multispectral Optoacoustic Tomography (MSOT)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Gastroparesis focused on measuring diabetic gastroparesis, MSOT

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Study group 1

    Study group 2

    Study group 3

    Study group 4

    Arm Description

    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%

    Outcomes

    Primary Outcome Measures

    Gastric emptying time
    Gastric emptying time based on MSOT imaging of ICG-signal intensity

    Secondary Outcome Measures

    Correlation of acquired hemoglobin signal with disease activity
    Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity
    Correlation of acquired hemoglobin signal with disease duration
    Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    June 28, 2023
    Sponsor
    University of Erlangen-Nürnberg Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05935852
    Brief Title
    Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
    Acronym
    TRANSPARENT
    Official Title
    Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 24, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Erlangen-Nürnberg Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Gastroparesis
    Keywords
    diabetic gastroparesis, MSOT

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Four Arms with different disease activity and duration
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group 1
    Arm Type
    Other
    Arm Description
    Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy
    Arm Title
    Study group 2
    Arm Type
    Other
    Arm Description
    Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy
    Arm Title
    Study group 3
    Arm Type
    Other
    Arm Description
    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%
    Arm Title
    Study group 4
    Arm Type
    Other
    Arm Description
    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%
    Intervention Type
    Device
    Intervention Name(s)
    Multispectral Optoacoustic Tomography (MSOT)
    Intervention Description
    Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
    Primary Outcome Measure Information:
    Title
    Gastric emptying time
    Description
    Gastric emptying time based on MSOT imaging of ICG-signal intensity
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    Correlation of acquired hemoglobin signal with disease activity
    Description
    Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity
    Time Frame
    6 hours
    Title
    Correlation of acquired hemoglobin signal with disease duration
    Description
    Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ferdinand Knieling
    Phone
    +4991318541151
    Email
    ferdinand.knieling@uk-erlangen.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emmanuel Nedoschill
    Email
    emmanuel.nedoschill@uk-erlangen.de

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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