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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03839667
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 40-70 years;
2. Newly diagnosed type 2 diabetes
* Duration of type 2 diabetes ≤ 2 years;
* Antidiabetic treatment maintained for at least 6 weeks before recruitment;
3. 7.0%≤ HbA1c \< 9.0%;
4. 25 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;
Exclusion Criteria:
1. History consistent with type 1 diabetes;
2. Insulin treatment;
3. Severe cardiovascular disease:
* current angina
* myocardial infarction within last six months
* heart failure
* symptomatic periphery vascular disease
4. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg;
5. Myocardial ischemia indicated by resting ECG;
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. Average weekly alcohol intake \>140 grams for men and \>70 grams for women;
9. ALT or AST levels more than twice the upper limit of the normal range or active liver diseases;
10. eGFR \<60 ml/min/1.73 m2, or serum creatinine \>1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria
11. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
12. Hemoglobin concentration \<130 g/l for men or \<120 g/l for women;
13. Past or present confirmed psychiatric illness or drug dependence;
14. History of food allergies;
15. Surgical history of digestive system;
16. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
17. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
18. Known to have metabolism-affecting diseases;
19. Known to have infectious diseases within last month;
20. Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;
21. Other acute diseases supported by clinical evidence which may contradict to the interventions;
22. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
23. Currently participating in another intervention study;
24. Failure to obtain informed consent from participant;
25. Any factors judged by the clinic team to be likely to limit adherence to interventions;
26. Any other medical condition judged by the clinic team not eligible for the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03839667
Study Brief:
Protocol Section:
NCT03839667