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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03794232
Eligibility Criteria:
Inclusion Criteria:
The following various situations need to be met at the same time in order to be selected:
* According to the diagnostic criteria for impaired glucose tolerance in the WHO Diabetes Diagnosis and Classification Standard in 1999: fasting blood glucose ≥6.1mmol/L and \<7.0mmol/L, blood glucose 2 hours after oral administration of 75g glucose ≥7.8mmol/L and \< 11.1mmol/L;
* BMI：20kg/㎡ ≤ BMI ≤ 35kg/㎡；
* Age ≥ 18 and ≤ 70 years old, gender is not limited;
* Voluntarily participate in the trial and sign the informed consent form.
Exclusion Criteria:
Any of the following circumstances should be excluded and cannot be selected:
* Acute cardiovascular and cerebrovascular events or myocardial infarction within 6 months;
* Laboratory examination: liver function AST or ALT ≥ 2.5 × ULN; renal function Cr \> 1.2 × ULN;
* Those with severe gastrointestinal diseases, such as active peptic ulcer, intestinal obstruction, etc.; those who have changed the history of normal structure of the gastrointestinal tract;
* Hypertensive patients with poor blood pressure control (blood pressure SBP ≥ 160 mmHg and / or DBP ≥ 100 mmHg);
* Those with severe blood system diseases;
* Those with other endocrine system diseases, such as hyperthyroidism or hypercortisolism;
* Those who have a stress state or have secondary blood glucose elevation factors (such as those who take glucocorticoids);
* Women who are pregnant or breast-feeding, who are planning to be pregnant or who are not willing to contraception during the study;
* Drug or other drug abusers;
* Those who may be allergic to the test drug;
* Those who have participated in other drug trials within 3 months;
* Those who are unable to cooperate with mental illness;
* Other circumstances The investigator believes that it is not suitable for the group.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03794232
Study Brief:
Protocol Section:
NCT03794232