Diabetes Mellitus, Type 1DiaFLIPNCT06068114
Gastric Pathophysiology in Diabetes
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Institute for Clinical and Experimental Medicine at 5 sites in 2 countries.
Trial summary
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Functional Dyspepsia
- How many people
- 120 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Oct 2022to 30 Jun 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic patients treated in any of the participating centers.
Who may be able to join
- Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years
Who cannot join
- Diabetes mellitus type II being treated with a diet only
- Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization
- Concomitant treatment with more than one prokinetic agent
- Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
- Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)
- Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
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- Severe coagulopathy
- Esophageal or gastric varices and /or portal gastropathy
- Advanced liver cirrhosis
- Pregnancy or puerperium
- Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
- The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed.
- Systemic connective tissue disorder
- Inability to obtain informed consent
- Any other condition, which in the opinion of the investigator would interfere with study requirements
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Eva Evinová, MD contact
5 sites in 2 countries
Czechia4 sites, 4 recruiting
- Recruiting
Nemocnice AGEL Ostrava-Vítkovice a. s.
Ostrava, 703 00
Eva Evinová, MD, eva.evinova@vtn.agel.cz
- Recruiting
University Hospital Ostrava
Ostrava, 708 52
Marek Buzga, PhD, marek.buzga@osu.cz
- Recruiting
Institute for Clinical and Experimental Medicine
Prague, 14021
Dagmar Šimková, MD, dagmar.simkova@ikem.cz
- Recruiting
Military University Hospital Prague
Prague, 16902
Jan Bures, prof., bures.jan@uvn.cz
Slovakia1 site, 1 recruiting
- Recruiting
University Hospital Trnava
Trnava, 917 02
Rastislav Hustak, PhD, rastislav.hustak@fntt.sk
About this study
Official title: Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated.
For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Functional Dyspepsia, Gastroparesis, Healthy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pyloric distensibility
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
Measured: At baseline and after 12 months
Secondary outcomes (7)
GCSI score
Gastroparesis Cardinal Symptom Index questionnaire: The score ranges from 0 to 5 for each symptom (9 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate more severe symptoms.
Measured: At baseline and after 6 and 12 months
PAGI-SYM score
Patient Assessment of Gastrointestinal Disorders Symptom Severity Index questionnaire: The score ranges from 0 to 5 for each symptom (20 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate more severe symptoms.
Measured: At baseline and after 6 and 12 months
PAGI-QoL score
Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life questionnaire: The score ranges from 0 to 5 for each symptom (30 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate lower quality fo life.
Measured: At baseline and after 6 and 12 months
Gastric emptying by scintigraphy
Gastric scintigraphy protocol endorsed by both American Neurogastroenterology and Motility Society and American Nuclear Medicine Society will be used to assess gastric emptying with a standard 200 kcal, 2% fat egg-substitute test meal. Gamma camera images will be obtained immediately after meal ingestion and then at 1, 2, 3 and 4 hours. Diagnostic criterion for delayed gastric emptying is defined as the percentage of gastric retention >60% at 2 h or ≥ 10% at 4 h or both. Half-time (T1/2) emptying time will also be calculated. At least 72 hours before gastric emptying test, narcotics and other medications that can interfere with gastric emptying will be discontinued.
Measured: At baseline and after 12 months
Gastric emptying by breath test
Gastric emptying assessed using 13C breath test with octanoic acid. This measurement is an alternative to the measurement of gastric emptying by scintigraphy. The choice depends on the practice in a particular center.
Measured: At baseline and after 12 months
Electrogastrography
Surface electrogastrography (EGG) is a non-invasive method for the evaluation of myoelectric activity of the stomach. Gastric pacemaker generates electrical phenomenon termed "gastric slow waves", which originate in a "pacemaker region" located on the greater curvature near the junction of the fundus and gastric body. EGG recordings will be accomplished by means of EGG Stand (MMS, Enschede, the Netherlands) with a MMS software. Six active self-adhesive electrodes will be placed on the upper part of the abdomen, the 7th electrode (basal) will be placed in the left supraclavicular area. A special abdominal belt (respiratory sensor) will be used to identify possible artefacts due to breathing and body movements . All EGGs will be performed at a lying position in the morning after an overnight fasting. Basal EGG (under fasting condition) will be recorded for 20 minutes. A standard test breakfast will be served afterwards. Postprandial EGG will be recorded for next 40 min.
Measured: At baseline and after 12 months
Autonomic function testing
Autonomic function testing will be performed by the golden standard battery of tests introduced by Ewing. The test involves four phases: (1) resting phase (5 min), (2) deep breathing test (1 min of 0,1 Hz breathing rate), (3) short Valsalva maneuvers (1 min), and (4) standing Tilt test (5 min). An ECG will be recorded during all phases. The Heart rate variability triangular index will be assessed.
Measured: At baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start5 Oct 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Poliklinika Agel, Dopravni zdravotnictvi a.s.
- Responsible party
- Principal investigator, Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068114
- Sponsor's protocol ID
- DiaFLIP
- Acronym
- DiaFLIP
- Status last verified
- May 2024
- First submitted
- 26 Sep 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06068114
- Acronym / sponsor ID
- DiaFLIP / DiaFLIP
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Functional Dyspepsia, Gastroparesis, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Poliklinika Agel, Dopravni zdravotnictvi a.s.
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Oct 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.
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated.
For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | –Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients treated in any of the participating centers.
Key inclusion criteria (1 listed)
- Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years
Key exclusion criteria (15 listed)
- Diabetes mellitus type II being treated with a diet only
- Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization
- Concomitant treatment with more than one prokinetic agent
- Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
- Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pyloric distensibility
Time frame: At baseline and after 12 months
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
7 secondary outcomes
GCSI score
Time frame: At baseline and after 6 and 12 months
PAGI-SYM score
Time frame: At baseline and after 6 and 12 months
PAGI-QoL score
Time frame: At baseline and after 6 and 12 months
Gastric emptying by scintigraphy
Time frame: At baseline and after 12 months
Gastric emptying by breath test
Time frame: At baseline and after 12 months
Electrogastrography
Time frame: At baseline and after 12 months
Autonomic function testing
Time frame: At baseline and after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Eva Evinová, MD contact
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Institute for Clinical and Experimental Medicine at 5 sites in 2 countries.
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 1 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Evinová, MD (eva.evinova@vtn.agel.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pyloric distensibility (time frame: At baseline and after 12 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 17 May 2024.