Status:
RECRUITING
Gastric Pathophysiology in Diabetes
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
Poliklinika Agel, Dopravni zdravotnictvi a.s.
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06068114
Start Date
October 5 2022
End Date
June 30 2027
Last Update
May 17 2024
Active Locations (5)
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1
Nemocnice AGEL Ostrava-Vítkovice a. s.
Ostrava, Czechia, 703 00
2
University Hospital Ostrava
Ostrava, Czechia, 708 52
3
Institute for Clinical and Experimental Medicine
Prague, Czechia, 14021
4
Military University Hospital Prague
Prague, Czechia, 16902