Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT03972904
Eligibility Criteria:
Inclusion Criteria:
1. Comply with the diagnostic criteria for type 2 diabetes in the 1999 WHO Diabetes Diagnosis and Classification Standard:
Clear clinical record of fasting blood glucose (FPG) ≥ 7mmol / L or 75g OGTT（2h） ≥ 11.1mmol / L;
2. T2DM of duration \> 1 year（diagnosis based on the 1999 WHO Diabetes Diagnosis and Classification Standard in China ）;
3. Body mass index: 25 kg/m2 \< BMI ≤ 35kg/m2;
4. Men and women aged 18-75 years;
5. Volunteer to participate in the trial and sign the informed consent form .
Exclusion Criteria:
1. Acute cardiovascular and cerebrovascular events or myocardial infarction within previous 6 months;
2. Laboratory inspection:
Liver function: AST and / or ALT ≥ 2.5 × ULN; Renal function: Cr\>1.2×ULN;
3. People with severe gastrointestinal diseases, such as active peptic ulcer, intestinal obstruction, etc.;have a history of changes in the normal structure of the gastrointestinal tract;
4. Hypertensive patients with poor blood pressure control(blood pressure SBP≥160mmHg and / or DBP≥100mmHg);
5. Those with severe blood system diseases;
6. Combine other endocrine system diseases(such as hyperthyroidism or hypercortisolism);
7. Patients with stress or secondary blood glucose elevation(such as taking glucocorticoids);
8. Pregnant or lactating women,and women who are not willing to contraception during pregnancy or study;
9. Food or other drug abusers;
10. People who may be allergic to the test food;
11. Those who have participated in other food trials within 3 months;
12. Those who cannot co-operate with mental illness;
13. Other circumstances,which the researcher believes that it is not suitable for the group.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03972904
Study Brief:
Protocol Section:
NCT03972904