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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05914857
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 \~65 years old;
2. OGTT received within half a year and were diagnosed with prediabetes In accordance with the gout classification criteria of the American Diabetes Association: ① Fasting blood glucose (FPG)≥6.1 mmol/L and \< 7.0 mmol/L; ② The blood glucose (2h-PG) concentration at OGTT 2h was ≥7.8 and \< 11.1mmol/L; ③ Glycosylated hemoglobin (HbA1c) ≥5.7% and \< 6.4%;
3. No antidiabetic drugs (including traditional Chinese medicine) were taken within 6 months before screening;
4. Sign the informed consent form.
Exclusion Criteria:
1. Diagnosed with diabetes;
2. Taking medications that affect glucose and lipid metabolism (excluding thiazide diuretics at a daily dose of ≤ 12.5 mg);
3. Taking weight-loss drugs (including traditional Chinese medicine) within 6 months before screening;
4. Patients with acute infection, surgery, acute alcoholism, mental illness, etc;
5. Patients with liver and kidney dysfunction, severe chronic gastrointestinal disease, uncontrolled thyroid disease, cancer, and ventilator use;
6. Systolic blood pressure ≥180 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure ≥110 mmHg at screening;
7. Electrocardiogram within 12 weeks before screening indicating arrhythmia requiring urgent diagnosis or treatment (e.g., clinically newly identified severe arrhythmia or conduction disturbance), myocardial infarction, unstable angina, or stroke requiring cardiovascular and cerebrovascular intervention;
8. A history of traumatic amputation within the past year, or active skin ulcers, osteomyelitis, gangrene, or critical lower limb ischemia within the past 6 months;
9. Enrolled in drug/device clinical studies (including vaccines) within 12 weeks before screening;
10. Pregnant, lactating women, or those planning a recent pregnancy;
11. Allergic constitution or multi-drug allergy;
12. Receiving bariatric surgery within the past 2 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05914857
Study Brief:
Protocol Section:
NCT05914857