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

June 28, 2023 updated by: Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study group 1
Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
Other: Study group 2
Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
Other: Study group 3
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%
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
Other: Study group 4
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%
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying time
Time Frame: 6 hours
Gastric emptying time based on MSOT imaging of ICG-signal intensity
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of acquired hemoglobin signal with disease activity
Time Frame: 6 hours
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity
6 hours
Correlation of acquired hemoglobin signal with disease duration
Time Frame: 6 hours
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 24, 2023

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-TEMP915246-Bm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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