RecruitingNot ApplicableNCT06861062

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

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


Sponsor

Huazhong University of Science and Technology

Enrollment

2,500 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether taking vitamin D3 and yeast beta-glucan supplements can help control blood sugar and lower heart disease risk in people with type 2 diabetes. You may be eligible if... - You have been diagnosed with type 2 diabetes by a physician - You are between 40 and 79 years old (men or women) - You live near one of the study centers and can attend for the next 5 years - You are willing to participate and sign informed consent You may NOT be eligible if... - You had a major heart event (heart attack, stroke, heart failure, bypass surgery) in the past 6 months - You have severe diabetic kidney disease (eGFR below 30), advanced eye disease, or confirmed nerve damage - You have a history of cancer (except certain low-risk skin cancers) - You have a history of kidney stones, high blood calcium, or overactive parathyroid glands - You have severe liver, kidney, gastrointestinal, infectious, or psychiatric conditions - Your blood calcium is already at or above the upper limit of normal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin D3

Vitamin D3(cholecalciferol),1600 IU per day.

DIETARY_SUPPLEMENTyeast β-glucan

yeast β-glucan, 600mg per day.

DIETARY_SUPPLEMENTVitamin D placebo

Vitamin D placebo

DIETARY_SUPPLEMENTyeast 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

View Full Details on ClinicalTrials.gov

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NCT06861062


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