This study is a randomized, double-blind, placebo-controlled trial involving 2,500 individuals aged 40-79 with type 2 diabetes (T2D). The trial includes a 2-year intervention period followed by a 3-year post-intervention follow-up. The primary objective is to investigate (a) the effect of daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) on glycemic control in patients with T2D and (b) whether daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) in patients with T2D. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on cardiometabolic risk factors, inflammatory markers, and liver and kidney function indicators, and assessing whether such supplementation reduces the risk of cardiovascular disease, microvascular complications and mortality over the 3-year post-intervention period.
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.
History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary revascularization) within the past 6 months;
History of severe diabetic microvascular complications (diabetic nephropathy with an estimated glomerular filtration rate (eGFR) < 30 mL/(min·1.73m²), proliferative diabetic retinopathy, confirmed diabetic peripheral neuropathy with abnormal nerve conduction studies or small fiber neuropathy testing);
History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis;
History of kidney stones, hypercalcemia, or hyperparathyroidism;
Factorial
Vitamin D3
DrugVitamin D3(cholecalciferol),1600 IU per day.
yeast β-glucan
Dietary supplementyeast β-glucan, 600mg per day.
Vitamin D placebo
Dietary supplementVitamin D placebo
yeast β-glucan placebo
Dietary supplementyeast β-glucan placebo
Glycemic control
Change in HbA1c from baseline to the 24-month visit
Cardiovascular disease risk
Change in 10-year ASCVD risk score from baseline to the 24-month visit, assessed using China-PAR score, with a score range of 0-100%, where a higher score means a higher ASCVD risk
Blood 25(OH)D
Change in blood 25(OH)D concentrations from baseline to the 24-month visit
Major cardiovascular events
Time to the first occurrence of any of the following: myocardial infarction, hospitalized or treated heart failure, stroke, revascularization of coronary arteries, or cardiovascular deaths
Microvascular disease
Time to the first occurrence of any of the following: nephropathy, retinopathy, or neuropathy
All-cause mortality
Deaths from any causes
Other events
Incidence of other cardiovascular diseases (not listed above), cancer, infectious diseases and falls
Change in Health-related quality of life
Change in health-related quality of life from baseline to the 24-month visit, assessed using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, with a score range of 0-100, where a higher score means higher health-related quality of life
Change in Cognitive function (MoCA)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a one-page 30-point test. Scores range from 0 to 30, with a score of 26 or above considered normal. The change in score from baseline to 24 months will be calculated.
Change in Cognitive function (MMSE)
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The MMSE is a 30-point questionnaire. Scores range from 0 to 30, with different cut-off points for normal cognition based on education level: \>17 for illiterate, \>20 for individuals with ≤6 years of education, and \>24 for individuals with \>6 years of education. The change in score from baseline to 24 months will be calculated.
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