Status:
COMPLETED
The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
Lead Sponsor:
University of Adelaide
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Brief 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 hi...
Detailed Description
A total of 100 newly diagnosed Han Chinese patients with type 2 diabetes will be recruited into the study through the Department of Endocrinology, Nanjing first Hospital. Following enrolment, patients...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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);
- Patients with infected injection site or coagulation disorders;
- Patients who are pregnant.
Key Trial Info
Start Date :
January 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05284344
Start Date
January 24 2021
End Date
December 31 2023
Last Update
May 9 2024
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000