Gastric Pathophysiology in Diabetes

Официальное название

Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus

Обзор

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.

Первичные конечные точки

• Pyloric distensibility [Срок оценки: At baseline and after 12 months]

Вторичные конечные точки (7)

• GCSI score [Срок оценки: At baseline and after 6 and 12 months]
• PAGI-SYM score [Срок оценки: At baseline and after 6 and 12 months]
• PAGI-QoL score [Срок оценки: At baseline and after 6 and 12 months]
• Gastric emptying by scintigraphy [Срок оценки: At baseline and after 12 months]
• Gastric emptying by breath test [Срок оценки: At baseline and after 12 months]
• Electrogastrography [Срок оценки: At baseline and after 12 months]
• Autonomic function testing [Срок оценки: At baseline and after 12 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Чехия · 4 центра

• Nemocnice AGEL Ostrava-Vítkovice a. s. — Ostrava
• University Hospital Ostrava — Ostrava
• Institute for Clinical and Experimental Medicine — Prague
• Military University Hospital Prague — Prague

Словакия · 1 центр

• University Hospital Trnava — Trnava

Идентификаторы

NCT: NCT06068114 · DiaFLIP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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