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

NCT06861062 | Recruiting DMC

• 1 other identifier: VD, Yeast β-Glucan in Diabetes
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Vitamin D; yeast β-glucan; Diabetes Mellitus, Type 2; Cardiovascular Disease; glycemic control

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  Change in HbA1c from baseline to the 24-month visit

  24 months

• 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

  24 months

Secondary Outcomes (29)

• Blood 25(OH)D

  24 months

• Major cardiovascular events

  60 months

• Microvascular disease

  60 months

• All-cause mortality

  60 months

• Change in fasting plasma glucose

  24 months

Other Outcomes (13)

• Other events

  60 months

• Change in Health-related quality of life

  24 months

• Change in Cognitive function (MoCA)

  24 months

Study Arms (4)

Vitamin D + yeast β-glucan

ACTIVE COMPARATOR

Drug: Vitamin D3; Dietary Supplement: yeast β-glucan

Vitamin D + yeast β-glucan placebo

ACTIVE COMPARATOR

Drug: Vitamin D3; Dietary Supplement: yeast β-glucan placebo

yeast β-glucan +Vitamin D placebo

ACTIVE COMPARATOR

Dietary Supplement: yeast β-glucan; Dietary Supplement: Vitamin D placebo

Vitamin D placebo + yeast β-glucan placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D placebo; Dietary Supplement: yeast β-glucan placebo

Interventions

Vitamin D3 DRUG

Vitamin D3(cholecalciferol),1600 IU per day.

Also known as: cholecalciferol

Vitamin D + yeast β-glucan; Vitamin D + yeast β-glucan placebo

yeast β-glucan DIETARY_SUPPLEMENT

yeast β-glucan, 600mg per day.

Vitamin D + yeast β-glucan; yeast β-glucan +Vitamin D placebo

Vitamin D placebo DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D placebo + yeast β-glucan placebo; yeast β-glucan +Vitamin D placebo

yeast β-glucan placebo DIETARY_SUPPLEMENT

yeast β-glucan placebo

Vitamin D + yeast β-glucan placebo; Vitamin D placebo + yeast β-glucan placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of severe liver disease, severe kidney disease, severe gastrointestinal disease, severe infectious diseases, severe sarcoidosis or other granulomatous diseases, severe mental illness, or any other condition considered unsuitable for participation judged by the clinic team;
• Laboratory evaluation:
• Blood calcium levels greater than or equal to the normal range for the clinical site's laboratory;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels higher than 3 times the normal range for the clinical site's laboratory;
• eGFR \< 30 mL/(min·1.73m²);
• Individuals currently taking vitamin D supplements (\>400 IU/day), calcium supplements (\>600 mg/day), yeast β-glucan supplements (\>250 mg/day), or those with a history of allergy or intolerance to vitamin D or prebiotic products;
• Participation in other clinical trials within the past 3 months;
• Planning to become pregnant within the next five years, or currently pregnant or breastfeeding.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (5)

Guangxi Medical College

Nanning, Guangxi, China

RECRUITING

Kailuan General Hospital

Tangshan, Hebei, China

RECRUITING

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

RECRUITING

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• An Pan, PHD

  School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Liu, PHD

CONTACT

86-15926238366; liugang026@hust.edu.cn

Tianyu Guo

CONTACT

86-18210047875; D202482059@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 6, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)