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.
Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years
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
Diabetic patients treated in any of the participating centers.
Case-control
Prospective
Not listed
Pyloric distensibility
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
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.
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.
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.
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.
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Institute for Clinical and Experimental Medicine
Lead sponsor
Poliklinika Agel, Dopravni zdravotnictvi a.s.
Collaborator
