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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935852

Collaborator

(none)

Enrollment

Arms

5.3

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Gastroparesis	Device: Multispectral Optoacoustic Tomography (MSOT)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Four Arms with different disease activity and durationFour Arms with different disease activity and duration

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 24, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Gastric emptying time [6 hours]
Gastric emptying time based on MSOT imaging of ICG-signal intensity

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ferdinand Knieling, PD Dr. med. Ferdinand Knieling, University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT05935852

Other Study ID Numbers:

23-TEMP915246-Bm

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ferdinand Knieling, PD Dr. med. Ferdinand Knieling, University of Erlangen-Nürnberg Medical School

diabetic gastroparesis

MSOT

Additional relevant MeSH terms:

Gastroparesis

Study Results

No Results Posted as of Jul 7, 2023