Clinical trial NCT06068114: Gastric Pathophysiology in Diabetes
Official title: Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Functional Dyspepsia
Gastroparesis
Healthy
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Poliklinika Agel, Dopravni zdravotnictvi a.s.
First posted: 2023-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients treated in any of the participating centers.

Brief 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.


Eligibility criteria: Inclusion Criteria (diabetic group):

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

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 informed consent
* Any other condition, which in the opinion of the investigator would interfere with study requirements

Primary outcomes:
measure: Pyloric distensibility
timeFrame: At baseline and after 12 months
Secondary outcomes:
measure: GCSI score
timeFrame: At baseline and after 6 and 12 months
measure: PAGI-SYM score
timeFrame: At baseline and after 6 and 12 months
measure: PAGI-QoL score
timeFrame: At baseline and after 6 and 12 months
measure: Gastric emptying by scintigraphy
timeFrame: At baseline and after 12 months
measure: Gastric emptying by breath test
timeFrame: At baseline and after 12 months
measure: Electrogastrography
timeFrame: At baseline and after 12 months
measure: Autonomic function testing
timeFrame: At baseline and after 12 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava-Vítkovice a. s.
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Prague
country: Czechia
facility: Military University Hospital Prague
city: Trnava
country: Slovakia
facility: University Hospital Trnava
Study officials:
References: