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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT06351566
Eligibility Criteria:
Inclusion Criteria:
1. Type 2 diabetes (meeting any of the following criteria):
Physician-diagnosed type 2 diabetes, use of oral hypoglycemic medication or insulin, fasting blood glucose ≥ 7.0 mmol/L, HbA1c ≥ 6.5% (48 nmol/L), 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L.
2. Men aged 35-70 years or women aged 35-70 years.
3. Convenient access to study centers.
4. Written informed consent obtained before any trial-related activities.
Exclusion Criteria:
1. History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).
2. History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).
3. History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).
4. History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).
5. Severe liver disease (such as cirrhosis), severe kidney disease (such as renal failure or requiring dialysis), or severe gastrointestinal disease (such as a history of bowel obstruction).
6. Kidney stones, hypercalcemia, parathyroid hormone abnormality.
7. Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis.
8. Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder.
9. Individuals with infectious diseases such as HIV/AIDS, viral hepatitis.
10. Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment.
11. In the past 3 months, those who have taken any vitamin D supplements exceeding 400 IU/day, calcium supplements exceeding 600 mg/day, prebiotics exceeding 2 g/day, or probiotics exceeding 10\^8 colony forming units/day.
12. History of allergy or intolerance to vitamin D, prebiotics, or starch.
13. Individuals with unhealthy habits: heavy alcohol consumption (\>80 grams/day for males, \>40 grams/day for females) or smoking (\>40 cigarettes/day).
14. Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues.
15. Those having participated in other clinical trials or studies in the past 3 months.
16. Those who are intent to become pregnant within the next two years, are currently pregnant, or breastfeeding.
17. Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT06351566
Study Brief:
Protocol Section:
NCT06351566