Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Cardiovascular Disease in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial
This study is a randomized, double-blind, placebo-controlled trial involving 8,000 individuals aged 40-79 with type 2 diabetes. The trial includes a 2-year intervention period followed by 3 years of follow-up. The primary objective is to investigate whether daily dietary supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the risk of major cardiovascular diseases, including myocardial infarction, stroke, treated or hospitalized heart failure, and cardiovascular deaths. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on all-cause mortality, microvascular disease, cognitive function, and other outcomes.
• Type 2 diabetes mellitus diagnosed by a physician based on the diagnostic criteria outlined in the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 Edition);
• Men or women aged 40-79 years;
• Convenient access to the study centers and permanent residence in the vicinity for the next five years;
• Voluntary participation and signed written informed consent.