Gastroparesis Due to Diabetes Mellitus Type IPATODIAGNCT05717205
Pathophysiology of Diabetic Gastroparesis
A study testing technetium scitigraphy in people with Gastroparesis Due to Diabetes Mellitus Type I, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The goal of this study is to explore the pathophysiology of diabetic gastroparesis by conducting an exploratory cohort study. Participants will be type 1 diabetes patients with and without gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroparesis Due to Diabetes Mellitus Type I
- What is being tested?
- technetium scitigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Feb 2023to 1 Jun 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- age 18-85
- Case group: Gastroparesis verified by technetium scintigraphy and a GCSI score ≥ 1.9
- Control group: Gastroparesis not confirmed by technetium scintigraphy and score GCSI score < 1.9
Who cannot join
- Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator.
- Recent gastrointestinal surgery
- Active duodenal/gastric ulcer disease,
- Diseases in the ventricle or previously complicated upper abdominal surgery
- Pregnancy or breast feeding
- Persons who, in the judgement of the investigator, may be unable to follow the protocol.
Show all 22Show fewer
- Parkinson disease
- metoclopramide 48 hours prior to scintigraphy
- domperidone 48 hours prior to scintigraphy
- macrolide antibiotics 48 hours prior to scintigraphy
- anti-cholinergic agents
- Tricycliv antidepressants
- Glucagon-like peptide-1 analogues
- Lithium
- Diphenhydramine
- dopamine agonists
- progesterone, L-dopa
- calcitonine
- ocreotide
- Interferon alfa
- sucralsulfate
- botulinum toxin injections (eg, Botox®) by pyloric injection.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, Capital Region, 2650
Melina S Hansen, MD, +4528304757, melina.svraka.hansen.01@regionh.dk
John G Karstensen, MD, +4540944465, john.gasdal.karstensen@regionh.dk
About this study
The goal of this study is to explore the pathophysiology of diabetic gastroparesis by conducting an exploratory cohort study. Participants will be type 1 diabetes patients with and without gastroparesis. Investigators will investigate
- Differences in nervefiber density and morphology
- Cellular and transcriptional changes and indices of glucosemetabolism between groups
Read the detailed description
Aims To perform an exploratory cohort study including 26 type 1 diabetes (DM1) patients aged 18-85 years with gastroparesis and 26 comparable DM1 diabetes patients without gastroparesis, investigating nerve fibre density and length in the mucosal and submucosal layer of the stomach (fundus, and antrum). A variety of molecular, biochemical and cellular experimental procedures will be performed on bloodsamples and tissue biopsies collected during gastroscopy exploring the pathophysiology of gastroparesis. In addition, we will compare differences in, measures of glucose metabolism in the two patient groups through bloodsamples.
Hypotheses
- Nerve fibre morphology in the stomach is different in type 1 diabetes patients with diabetic gastroparesis compared to diabetes patient without gastroparesis and associated with differences in glucose metabolism and the severity of autonomic and peripheral neuropathy.
- Patients with gastroparesis show loss of interstitial cells of Cajal (ICC) in the gastric body, antrum and fundus and have marked morphological changes indicative of injuries.
- Macrophages are thought to play a central role in diabetic gastroparesis, in which a loss of anti-inflammatory heme-oxygenase-1 (HO-1) positive macrophages leads to decreased protection against oxidative stress, resulting in damage to ICCs.
- In gastroparesis there is increased presence of fibrosis in the stroma and alteration in inflammatory cells.
- Patients with gastroparesis may have decreased levels of neurotransmitters such as NO and substance P.
- Gastroparesis may cause pathological alterations of enteric glial and ganglion cells and the cytoplasm of smooth muscle cells.
- Patients with gastroparesis have lower pyloric distensibility.
- Examining transcriptional changes in between groups will reveal new genes associated with disease development. Newly developed in vitro models make it possible to explore and correlate molecular biochemical and cellular factors to disease development and progression.
Study Design All participants will be type 1 diabetes patients attending treatment at Steno Diabetes Center Copenhagen (SDCC) or type 1 diabetes patients referred from other treatment facilities. Patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire and be asked if they have been diagnosed with gastroparesis. Patients with known gastroparesis or with a GCSI score ≥ 1.9 without known gastroparesis will be subject to a technetium scintigraphy. Patients without established gastroparesis and a GCSI score < 1.9 will also undergo technetium scintigraphy. A gastric content above 10%, 4 hours after meal ingestion will be considered the diagnostic threshold for gastroparesis Patients with gastroparesis will be considered as cases and patients without gastroparesis as control. All patients will have a gastroscopy to rule out other causes to gastro-intestinal symptoms. During gastroscopy, 8 biopsies will be obtained and endo-flip will be used to measure distesibility in pylorus. Tissue specimens and blood samples will be collected and used in various research-based analyses to understand the pathophysiology.
- Being tested
- technetium scitigraphy
- Keywords
- gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
technetium scitigraphyDiagnostic test
Also called gastroscopy with tissuesamples
patients will have a technetium scintraphy confirming or ruling out gastroparesis. Then the patients will have a gastroscopy with tissue samples from antrum and fundus. During gastroscopy an endo-flip ballon will meassure the distensibility in pylorus.
| Study group | Role | What they receive |
|---|---|---|
| cases with gastroparesis | Active comparator | patients with a gastroparesis symptom score index (GCSI) of > 1.9 will be considered as cases with gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism Receives: Diagnostic Test: technetium scitigraphy |
| Controls without gastroparesis | Active comparator | patients with a gastroparesis symptom score index (GCSI) of < 1.9 will be considered as controls without gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism Receives: Diagnostic Test: technetium scitigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucosal nerve length density (MNLD)
differences in mucosal nerve length density (MNLD) of the gastric fundus and antrum in diabetes patients with and without gastroparesis. MNLD will be assessed by confocal microscopy of mucosal biopsies obtained by oesophago-gastro-duodenoscopy.
Measured: 24 months
Secondary outcomes (9)
Nerve fibre morphology
Nerve fibre morphology assessed by confocal microscopy of mucosal biopsies obtained by esophago-gastro-duodenoscopy
Measured: 24 months
Differences in histology
Hematoxylin and eosin (HE) staining and c-KIT staining of immune cells, interstitial cells, glia cells, ganglion cells and smooth muscle cells and visualization under a microscope
Measured: 24 months
Transcriptional changes
Altered transcriptional changes in mRNA by NanoString.
Measured: 24 months
Differences in cell populations
Differences in cell populations by fluorescence-activated cell sorting (FACS).
Measured: 24 months
Differences in pyloric distensibility
Pyloric distensibility measurements by Endo-Flip.
Measured: 24 months
Differences in glucose metabolism
plasma glucose in mmol/L, HbA1c in mmol/mol, proinsulin C-peptide in pmol/L
Measured: 24 months
Differences in gastric emptying time
Gastric emptying time assessed by technetium scintigraphy.
Measured: 24 months
Differences in neuropathy measures
sensory tests that record sensation of touch, vibration, cooling and heat.
Measured: 24 months
Immunohistochemical differences
Immunohistochemical staining that uses antibodies to visualize the localization of particular proteins within single cells.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start16 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroparesis Due to Diabetes Mellitus Type IStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Melina Svraka Hansen, Hvidovre University Hospital
- Investigators
- Melina S Hansen, MD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717205
- Sponsor's protocol ID
- SJ-980
- Acronym
- PATODIAG
- Status last verified
- Apr 2023
- First submitted
- 12 Dec 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT05717205
- Acronym / sponsor ID
- PATODIAG / SJ-980
- Keywords
- gastroparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Steno Diabetes Center Copenhagen
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Feb 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 goal of this study is to explore the pathophysiology of diabetic gastroparesis by conducting an exploratory cohort study. Participants will be type 1 diabetes patients with and without gastroparesis. Investigators will investigate
- Differences in nervefiber density and morphology
- Cellular and transcriptional changes and indices of glucosemetabolism between groups
Detailed description
Aims To perform an exploratory cohort study including 26 type 1 diabetes (DM1) patients aged 18-85 years with gastroparesis and 26 comparable DM1 diabetes patients without gastroparesis, investigating nerve fibre density and length in the mucosal and submucosal layer of the stomach (fundus, and antrum). A variety of molecular, biochemical and cellular experimental procedures will be performed on bloodsamples and tissue biopsies collected during gastroscopy exploring the pathophysiology of gastroparesis. In addition, we will compare differences in, measures of glucose metabolism in the two patient groups through bloodsamples.
Hypotheses
- Nerve fibre morphology in the stomach is different in type 1 diabetes patients with diabetic gastroparesis compared to diabetes patient without gastroparesis and associated with differences in glucose metabolism and the severity of autonomic and peripheral neuropathy.
- Patients with gastroparesis show loss of interstitial cells of Cajal (ICC) in the gastric body, antrum and fundus and have marked morphological changes indicative of injuries.
- Macrophages are thought to play a central role in diabetic gastroparesis, in which a loss of anti-inflammatory heme-oxygenase-1 (HO-1) positive macrophages leads to decreased protection against oxidative stress, resulting in damage to ICCs.
- In gastroparesis there is increased presence of fibrosis in the stroma and alteration in inflammatory cells.
- Patients with gastroparesis may have decreased levels of neurotransmitters such as NO and substance P.
- Gastroparesis may cause pathological alterations of enteric glial and ganglion cells and the cytoplasm of smooth muscle cells.
- Patients with gastroparesis have lower pyloric distensibility.
- Examining transcriptional changes in between groups will reveal new genes associated with disease development. Newly developed in vitro models make it possible to explore and correlate molecular biochemical and cellular factors to disease development and progression.
Study Design All participants will be type 1 diabetes patients attending treatment at Steno Diabetes Center Copenhagen (SDCC) or type 1 diabetes patients referred from other treatment facilities. Patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire and be asked if they have been diagnosed with gastroparesis. Patients with known gastroparesis or with a GCSI score ≥ 1.9 without known gastroparesis will be subject to a technetium scintigraphy. Patients without established gastroparesis and a GCSI score < 1.9 will also undergo technetium scintigraphy. A gastric content above 10%, 4 hours after meal ingestion will be considered the diagnostic threshold for gastroparesis Patients with gastroparesis will be considered as cases and patients without gastroparesis as control. All patients will have a gastroscopy to rule out other causes to gastro-intestinal symptoms. During gastroscopy, 8 biopsies will be obtained and endo-flip will be used to measure distesibility in pylorus. Tissue specimens and blood samples will be collected and used in various research-based analyses to understand the pathophysiology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases with gastroparesis | Active comparator | Diagnostic Test: technetium scitigraphypatients with a gastroparesis symptom score index (GCSI) of > 1.9 will be considered as cases with gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism |
| Controls without gastroparesis | Active comparator | Diagnostic Test: technetium scitigraphypatients with a gastroparesis symptom score index (GCSI) of < 1.9 will be considered as controls without gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- age 18-85
- Case group: Gastroparesis verified by technetium scintigraphy and a GCSI score ≥ 1.9
- Control group: Gastroparesis not confirmed by technetium scintigraphy and score GCSI score < 1.9
Key exclusion criteria (22 listed)
- Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator.
- Recent gastrointestinal surgery
- Active duodenal/gastric ulcer disease,
- Diseases in the ventricle or previously complicated upper abdominal surgery
- Pregnancy or breast feeding
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 |
|---|---|---|
| technetium scitigraphyAlso: gastroscopy with tissuesamplespatients will have a technetium scintraphy confirming or ruling out gastroparesis. Then the patients will have a gastroscopy with tissue samples from antrum and fundus. During gastroscopy an endo-flip ballon will meassure the distensibility in pylorus. | Diagnostic test | Controls without gastroparesis, cases with gastroparesis |
Primary outcome
mucosal nerve length density (MNLD)
Time frame: 24 months
differences in mucosal nerve length density (MNLD) of the gastric fundus and antrum in diabetes patients with and without gastroparesis. MNLD will be assessed by confocal microscopy of mucosal biopsies obtained by oesophago-gastro-duodenoscopy.
9 secondary outcomes
Nerve fibre morphology
Time frame: 24 months
Differences in histology
Time frame: 24 months
Transcriptional changes
Time frame: 24 months
Differences in cell populations
Time frame: 24 months
Differences in pyloric distensibility
Time frame: 24 months
Differences in glucose metabolism
Time frame: 24 months
Differences in gastric emptying time
Time frame: 24 months
Differences in neuropathy measures
Time frame: 24 months
Immunohistochemical differences
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Melina S Hansen, MD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing technetium scitigraphy in people with Gastroparesis Due to Diabetes Mellitus Type I, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Melina S Hansen, MD (+4528304757, melina.svraka.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mucosal nerve length density (MNLD) (time frame: 24 months). 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 14 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.