Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes

Other illness

• History of macrovascular diseases (including Coronary heart disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral vascular disease, post coronary artery bypass surgery).
• History of diabetic microvascular complications (including diabetic nephropathy, diabetic retinopathy, or diabetic neuropathy).
• History of other cardiovascular diseases (including aortic stenosis, transient ischemic attack, angina pectoris, cardiac arrest, complex ventricular arrhythmias, or surgery of cardiovascular diseases).
• History of cancer, excluding non-melanoma skin cancer or cancers with a good prognosis (such as stage 1 cervical cancer).
• 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).
• Sarcoidosis or other granulomatous diseases, such as active chronic pulmonary tuberculosis or Wegener's granulomatosis.
• Any mental disorders, such as schizophrenia, other mental disorders, or bipolar disorder.
• Individuals with infectious diseases such as HIV/AIDS, viral hepatitis.
• Individuals requiring long-term hospitalization or those with other serious illnesses requiring immediate hospital treatment.
• History of allergy or intolerance to vitamin D, prebiotics, or starch.
• Individuals with cognitive impairment, inability to communicate properly, inability to take care of themselves, or those with mobility issues.

Lab values

• 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.
• Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation.

Other

• Kidney stones, hypercalcemia, parathyroid hormone abnormality.
• Individuals with unhealthy habits: heavy alcohol consumption (\>80 grams/day for males, \>40 grams/day for females) or smoking (\>40 cigarettes/day).
• Those having participated in other clinical trials or studies in the past 3 months.
• Those who are intent to become pregnant within the next two years, are currently pregnant, or breastfeeding.

• 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.
• Men aged 35-70 years or women aged 35-70 years.
• Convenient access to study centers.
• Written informed consent obtained before any trial-related activities.