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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT04919603
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 18-65 years;
2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
Normal glucose metabolism:
* FBG\<5.6mmol/L and
* 2h-PG\<7.8mmol/L and
* HbA1c\<5.7%;
Pre-diabetes:
* 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
* 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
* 5.7% ≤ HbA1c ≤ 6.4%;
Newly diagnosed diabetes:
o Duration of type 2 diabetes is less than 5 years;
3. No insulin treatment;
4. 23 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;
Exclusion Criteria:
Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
Criteria: Inclusion Criteria:
1. Men and women aged 18-65 years;
2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes
Normal glucose metabolism:
* FBG\<5.6mmol/L and
* 2h-PG\<7.8mmol/L and
* HbA1c\<5.7%;
Pre-diabetes:
* 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
* 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
* 5.7% ≤ HbA1c ≤ 6.4%;
Newly diagnosed diabetes:
o Duration of type 2 diabetes is less than 5 years;
3. No insulin treatment;
4. 23 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;
Exclusion Criteria:
1. Severe cardiovascular disease:
* current angina
* myocardial infarction or stroke within last six months
* heart failure (NYHA grading III\~IV)
* symptomatic periphery vascular disease
2. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg;
3. Myocardial ischemia indicated by resting ECG;
4. Cardiac dysfunction indicated by Echocardiogram;
5. Abnormal HS-TNT or NT-proBNP concentration;
6. Foot ulcers, peripheral neuropathy or skeletal disorders;
7. Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase
8. ALT or AST levels more than three times the upper limit of the normal range or active liver diseases;
9. eGFR \<60 ml/min/1.73 m2, or serum creatinine \>1.5 mg/dl for men or 1.3mg/dl for women; or macro albuminuria (urine albumin/creatinine\>300mg/g)
10. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
11. Past or present confirmed psychiatric illness or drug dependence;
12. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
13. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
14. Known to have metabolism-affecting diseases;
15. Other acute diseases supported by clinical evidence which may contradict to the interventions;
16. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
17. Currently participating in another intervention study;
18. Failure to obtain informed consent from participant;
19. Any factors judged by the clinic team to be likely to limit adherence to interventions;
20. Any other medical condition judged by the clinic team not eligible for the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04919603
Study Brief:
Protocol Section:
NCT04919603