Diabetic GastroparesisTRANSPARENTNCT05935852
Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
A study testing Multispectral Optoacoustic Tomography (MSOT) in people with Diabetic Gastroparesis, run by University of Erlangen-Nürnberg Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 24 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
No sites are listed yet.
Emmanuel Nedoschill contact
About this study
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.
Read the 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.
- Conditions
- Diabetic Gastroparesis
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
- Keywords
- diabetic gastroparesis, MSOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Device
Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
| Study group 2 | Other | Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
| Study group 3 | Other | 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% Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
| Study group 4 | Other | 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% Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
Gastric emptying time based on MSOT imaging of ICG-signal intensity
Measured: 6 hours
Secondary outcomes (2)
Correlation of acquired hemoglobin signal with disease activity
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease activity
Measured: 6 hours
Correlation of acquired hemoglobin signal with disease duration
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with disease duration
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion24 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Four Arms with different disease activity and duration
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935852
- Sponsor's protocol ID
- 23-TEMP915246-Bm
- Acronym
- TRANSPARENT
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT05935852
- Acronym / sponsor ID
- TRANSPARENT / 23-TEMP915246-Bm
- Conditions
- Diabetic Gastroparesis
- Keywords
- diabetic gastroparesis, MSOT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four Arms with different disease activity and duration
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Other | Device: Multispectral Optoacoustic Tomography (MSOT)Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, with diabetic neuropathy |
| Study group 2 | Other | Device: Multispectral Optoacoustic Tomography (MSOT)Multispectral Optoacoustic Tomography (MSOT) of the gastric antrum and terminal ileum in patients with T1DM, aged> 18 years, without diabetic neuropathy |
| Study group 3 | Other | Device: Multispectral Optoacoustic Tomography (MSOT)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% |
| Study group 4 | Other | Device: Multispectral Optoacoustic Tomography (MSOT)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% |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT)Non-invasive transcutaneous imaging of endogenous and exogenous chromophores via infrared and near-infrared laser pulses | Device | Study group 1, Study group 2, Study group 3, Study group 4 |
Primary outcome
Gastric emptying time
Time frame: 6 hours
Gastric emptying time based on MSOT imaging of ICG-signal intensity
2 secondary outcomes
Correlation of acquired hemoglobin signal with disease activity
Time frame: 6 hours
Correlation of acquired hemoglobin signal with disease duration
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
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To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
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Washed Microbiota Transplantation for Diabetic Gastroparesis
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Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Nedoschill contact
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral Optoacoustic Tomography (MSOT) in people with Diabetic Gastroparesis, run by University of Erlangen-Nürnberg Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferdinand Knieling (+4991318541151, ferdinand.knieling@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying time (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.