The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 D… (NCT05284344) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
China78 participantsStarted 2021-01-24
Plain-language summary
Gastric emptying is now recognized as a major determinant of the blood glucose response to carbohydrate in both health and type 2 diabetes (T2D). While patients with longstanding diabetes exhibit a high prevalence of delayed gastric emptying, i.e. gastroparesis, patients with fewer complications are often associated with accelerated gastric emptying, which exacerbates postprandial glycaemic excursions. Moreover, gastric emptying appears to be more rapid in Han Chinese patients with T2D, as compared to Caucasian patients with T2D.
The proposed study will (i) compare the rate of gastric emptying in newly diagnosed, Chinese patients with T2D to non-diabetic controls, (ii) evaluate the relationship between gastric emptying and glycaemic indices, including measures of glucose variability, and (iii) determine whether gastric emptying is altered by glucose-lowering therapies.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients newly diagnosed of type 2 diabetes as defined by published Criteria of World Health Organization in 1999; with HbA1c ≥ 7%, age ≥ 18 years of age and ≤ 80 years old, and willing to receive anti-diabetic treatments,
✓. Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes
Exclusion criteria
✕. Patients with a fasting blood glucose ≤ 3.9mmol/L;
✕. Patients with insulin allergy;
✕. Patients with severe gastrointestinal symptoms and diseases;
✕. Patients with gastrointestinal surgery history;
✕. Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin);
✕. Patients with major cardiovascular disease event (e.g., stroke, symptomatic peripheral artery disease, myocardial infarction, percutaneous coronary or peripheral artery angioplasty or coronary artery bypass surgery) in the previous 6 months;
What they're measuring
1
Change in Gastric-half emptying time of the 75 g glucose drink
Timeframe: Baseline, 1 month and 3 months in diabetic group
2
Gastric-half emptying time of the 75 g glucose drink
Timeframe: Baseline in both diabetic and non-diabetic group
✕. Patients with liver dysfunction (aspartate aminotransferase or alanine aminotransferase level of more than two times the upper limit of normal range) or renal dysfunction (creatinine \> 150 μmol/L or GFR \< 60 mL/min/1.73m2);
✕. Patients with severe anemia and hemoglobin disorders (Hb \< 60 g/L);