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Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
Sponsor: Huazhong University of Science and Technology
Summary
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.
Official title: Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2025-04-08
Completion Date
2032-12-31
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Vitamin D3
Vitamin D3(cholecalciferol),1600 IU per day.
yeast β-glucan
yeast β-glucan, 600mg per day.
Vitamin D placebo
Vitamin D placebo
yeast β-glucan placebo
yeast β-glucan placebo
Locations (5)
Guangxi Medical College
Nanning, Guangxi, China
Kailuan General Hospital
Tangshan, Hebei, China
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, China
Huazhong University of Science and Technology
Wuhan, Hubei, China
Sichuan University
Chengdu, Sichuan, China