Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Glycemic control — 24 months
Change in HbA1c from baseline to the 24-month visit - Cardiovascular disease risk — 24 months
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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangxi Medical College | Nanning | Guangxi | Recruiting |
| Kailuan General Hospital | Tangshan | Hebei | Recruiting |
| Sinopharm Dongfeng General Hospital | Shiyan | Hubei | Recruiting |
| Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Sichuan University | Chengdu | Sichuan | Recruiting |
More Huazhong University of Science and Technology trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06861062 on ClinicalTrials.gov ↗ ← All trials in China