Type 2 Diabetes Clinical Trial
Official title:
The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
Verified date | May 2024 |
Source | University of Adelaide |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. 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, 2. Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes Exclusion Criteria: 1. Patients with a fasting blood glucose = 3.9mmol/L; 2. Patients with insulin allergy; 3. Patients with severe gastrointestinal symptoms and diseases; 4. Patients with gastrointestinal surgery history; 5. 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); 6. 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; 7. 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); 8. Patients with severe anemia and hemoglobin disorders (Hb < 60 g/L); 9. Patients with infected injection site or coagulation disorders; 10. Patients who are pregnant. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
University of Adelaide | The First Affiliated Hospital with Nanjing Medical University |
China,
Goyal RK. Gastric Emptying Abnormalities in Diabetes Mellitus. N Engl J Med. 2021 May 6;384(18):1742-1751. doi: 10.1056/NEJMra2020927. No abstract available. — View Citation
Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25. — View Citation
Wang X, Xie C, Marathe CS, Malbert CH, Horowitz M, Jones KL, Rayner CK, Sun Z, Wu T. Disparities in gastric emptying and postprandial glycaemia between Han Chinese and Caucasians with type 2 diabetes. Diabetes Res Clin Pract. 2020 Jan;159:107951. doi: 10.1016/j.diabres.2019.107951. Epub 2019 Nov 29. — View Citation
Watson LE, Xie C, Wang X, Li Z, Phillips LK, Sun Z, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric Emptying in Patients With Well-Controlled Type 2 Diabetes Compared With Young and Older Control Subjects Without Diabetes. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3311-3319. doi: 10.1210/jc.2018-02736. — View Citation
Xie C, Huang W, Wang X, Trahair LG, Pham HT, Marathe CS, Young RL, Jones KL, Horowitz M, Rayner CK, Wu T. Gastric emptying in health and type 2 diabetes: An evaluation using a 75 g oral glucose drink. Diabetes Res Clin Pract. 2021 Jan;171:108610. doi: 10.1016/j.diabres.2020.108610. Epub 2020 Dec 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Gastric-half emptying time of the 75 g glucose drink | The Change in gastric-half emptying time (min) before and after the treatment | Baseline, 1 month and 3 months in diabetic group | |
Primary | Gastric-half emptying time of the 75 g glucose drink | The difference in gastric-half emptying time (min) between subjects with and without type 2 diabetes | Baseline in both diabetic and non-diabetic group | |
Secondary | The mean blood glucose level | The mean blood glucose level (mmol/L) during the 24 hours continuous glucose monitoring. | Baseline, 1 month and 3 months in the diabetic group | |
Secondary | The mean amplitude of glycemic excursion | The mean amplitude of glycemic excursion (mmol/L) during the 24 hours continuous glucose monitoring. | Baseline, 1 month and 3 months in the diabetic group | |
Secondary | The percentage of blood glucose levels within the target range | The percentage of blood glucose levels within the target range (%) during the 24 hours continuous glucose monitoring. | Baseline, 1 month and 3 months in the diabetic group | |
Secondary | Serum insulin concentrations | The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum insulin (mU/L) in response to a 75 g glucose drink before and after the treatment. The incremental area under the curve (iAUC) is calculated using the trapezoidal rule. |
t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Serum C-peptide concentrations | The differences in the incremental area under the curve from 0 to 180 min (iAUC0-180min) for serum C-peptide (ng/mL) in response to a 75 g glucose drink before and after the treatment. | t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Serum total GLP-1 concentrations | The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum total GLP-1 (pmol/L) in response to a 75 g glucose drink before and after the treatment. | t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Serum total GIP concentrations | The differences in the incremental under the curve from 0 to 180 min (iAUC0-180min) for serum total GIP (pmol/L) in response to a 75 g glucose drink before and after the treatment. | t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Serum bile acid concentrations | The differences in the fasting serum bile acid concentrations (µmol/L) before and after the treatment. | Baseline, 1 month and 3 months in the diabetic group | |
Secondary | Systolic blood pressure | The differences in systolic blood pressure (mmHg) in response to the 75 g glucose drink before and after the treatment. | t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Diastolic blood pressure | The differences in diastolic blood pressure (mmHg) in response to the 75 g glucose drink before and after the treatment. | t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group | |
Secondary | Heart rate | The differences in heart rate (beats/min) in response to the 75 g glucose drink before and after the treatment. | t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group |
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