ClinicalTrials.gg
RecruitingNCT06068114DiaFLIPUpdated Nov 12, 2026

Gastric Pathophysiology in Diabetes

An observational study in Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 and Functional Dyspepsia, sponsored by Institute for Clinical and Experimental Medicine. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Institute for Clinical and Experimental Medicine · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 69 studies in Diabetes Mellitus, Type 1 with a site in Czechia — 10 open to participants now, 15 under way, 3 of them phase 3. Diabetes Mellitus, Type 1 · Czechia.

Planned enrollment
7th of 11
120 · median 123
Started
2022
with 3 others
Observational
11 of 69
4 open now
Primary completion
2027-06
later than 9 of 14 live
Registered
56th of 69
by date
Lead sponsor
3 of 69
Institute for Clinical and Experimental Medicine

Among the 69 studies in Diabetes Mellitus, Type 1 with a site in Czechia, this one is the 7th largest by planned enrollment of the 11 observational ones that give a count, is one of 4 that started in 2022, is one of 11 observational ones, reaches primary completion later than 9 of the 14 other live ones, and was the 56th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

10 of the 69 studies in Diabetes Mellitus, Type 1 with a site in Czechia are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Czechia have not opened yet or have stopped. Only those recruiting at a site in Czechia →

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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. 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.

03

Conditions studied

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Functional Dyspepsia
  • Gastroparesis
  • Healthy
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Diabetic patients treated in any of the participating centers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years

Exclusion criteria

Exclusion Criteria (diabetic group):

  • 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.)
  • 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
  • Any other condition, which in the opinion of the investigator would interfere with study requirements
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Diabetic patients

    Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis

  • Healthy controls
06

What researchers measure

Primary outcomes

  1. Pyloric distensibility

    Pyloric distensibility measured by impedance planimetry (EndoFLIP device)

    Time frame: At baseline and after 12 months

Secondary outcomes

  1. 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.

    Time frame: At baseline and after 6 and 12 months

  2. 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.

    Time frame: At baseline and after 6 and 12 months

  3. 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.

    Time frame: At baseline and after 6 and 12 months

  4. 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.

    Time frame: At baseline and after 12 months

  5. 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.

    Time frame: At baseline and after 12 months

  6. 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.

    Time frame: At baseline and after 12 months

  7. 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.

    Time frame: At baseline and after 12 months

07

Study locations

5 of 5 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Jun 2027, 56 months after the start.

Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 56 months is above that.

Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Oct 5, 2023
StartActual
Oct 5, 2022
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date, responsible party and site details
1 update, last Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Minor edits only
    + 3 other changes: verification date, responsible party and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06068114
Lead sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Poliklinika Agel, Dopravni zdravotnictvi a.s.
Responsible party
Prof. Jan Martinek, MD, PhD, AGAF (Prof. Jan Martínek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine) — Principal investigator
First posted
Oct 5, 2023
Start date
Oct 5, 2022
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Eva Evinová, MD
Contact
eva.evinova@vtn.agel.cz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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