NCT05284344Completed
The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 9 May 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 78 (actual)
- First submitted
- 24 Feb 2022
- Start date
- 24 Jan 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Adelaide
- Diseases
- Type 2 diabetes
- NCT number
- NCT05284344
What you commit to
- Study type: Observational
- Participants enrolled: 78
- From 24 Jan 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Patients with insulin allergy;
- Patients with severe gastrointestinal symptoms and diseases;
- Patients with infected injection site or coagulation disorders;
Lab values
- Patients with a fasting blood glucose ≤ 3.9mmol/L;
- 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);
Other
- Patients who are pregnant.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.