Actively Recruiting
Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
Led by Huazhong University of Science and Technology · Updated on 2026-02-02
2500
Participants Needed
5
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes by a doctor according to Chinese guidelines (2024 edition)
- Men or women aged 40 to 79 years
- Living near the study centers with easy access for the next five years
- Willing to participate and able to provide written informed consent
You will not qualify if you...
- Had clinical cardiovascular disease (heart attack, heart failure, stroke, coronary procedures) in the past 6 months
- Severe diabetic complications such as kidney disease with eGFR below 30, advanced retinopathy, or confirmed peripheral neuropathy
- History of cancer except non-melanoma skin cancer or cancers with good prognosis
- History of kidney stones, high blood calcium, or parathyroid problems
- Severe liver, kidney, gastrointestinal, infectious, granulomatous, or mental illness, or other conditions judged unsuitable
- Abnormal lab results including high blood calcium, ALT or AST over 3 times normal, or eGFR below 30
- Taking vitamin D supplements over 400 IU/day, calcium over 600 mg/day, or yeast beta-glucan over 250 mg/day, or allergic to vitamin D or prebiotic products
- Participated in another clinical trial in the past 3 months
- Pregnant, breastfeeding, or planning pregnancy within 5 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Guangxi Medical College
Nanning, Guangxi, China
Actively Recruiting
2
Kailuan General Hospital
Tangshan, Hebei, China
Actively Recruiting
3
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, China
Actively Recruiting
4
Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
G
Gang Liu, PHD
CONTACT
T
Tianyu Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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