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Diabetes Mellitus, Type 2NCT06861062

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

A study testing Vitamin D3 and yeast β-glucan in people with Diabetes Mellitus, Type 2, run by Huazhong University of Science and Technology at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 79 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Vitamin D3 and yeast β-glucan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,500 participants
Where
5 sitesChina
Study dates
8 Apr 2025to 31 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

China5 sites, 5 recruiting
  • Sichuan University

    Chengdu, Sichuan

    Jiayuan Li

    Recruiting
  • Guangxi Medical College

    Nanning, Guangxi

    Qiuli Chen

    Recruiting
  • Sinopharm Dongfeng General Hospital

    Shiyan, Hubei

    Kun Yang

    Recruiting
  • Kailuan General Hospital

    Tangshan, Hebei

    Shuohua Chen

    Recruiting
  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Gang Liu, 86-15926238366, liugang026@hust.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

The goal of this randomized, double-blind, placebo-controlled trial, with a 2×2 factorial design in individuals with type 2 diabetes (T2D), is to investigate (a) the effect of daily dietary supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) on glycemic control in patients with T2D and (b) whether vitamin D3 (1600 IU) or yeast β-glucan (600 mg) supplementation reduces the predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) in patients with T2D. Approximately 2,500 subjects aged 40-79 with T2D will be included in this study. Eligible participants will be randomly assigned to one of four groups: (1) daily vitamin D3 (1600 IU) and yeast β-glucan (600 mg); (2) daily vitamin D3 (1600 IU) and placebo for yeast β-glucan; (3) daily placebo for vitamin D3 and yeast β-glucan (600 mg); or (4) daily placebo for vitamin D3 and placebo for yeast β-glucan. At baseline, questionnaires will be administered to collect data on sociodemographic factors, lifestyle habits, health status, cognitive function, and medical conditions, et al. Participants will also undergo physical measurements, and blood, urine, and feces samples will be collected at study centers. The study includes a 2-year intervention period followed by a 3-year post-intervention follow-up. Participants in all groups will take four capsules daily for 2 years: two capsules containing either vitamin D or its placebo and two capsules containing either yeast β-glucan or its placebo. During the 2-year intervention period, questionnaires, physical measurements, and sample collection will be conducted at 6, 12, and 24 months. This trial will also evaluate the effects of supplementation on cardiometabolic risk factors, inflammatory markers, and liver and kidney function indicators, and assess whether it reduces the risk of cardiovascular disease, microvascular complications, and mortality over the 3-year post-intervention period, providing scientific evidence for the health effects of vitamin D or yeast β-glucan in the T2D population.

Being tested
Vitamin D3, yeast β-glucan, Vitamin D placebo, yeast β-glucan placebo
Keywords
Vitamin D, yeast β-glucan, Diabetes Mellitus, Type 2, Cardiovascular Disease, glycemic control
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Drug

    Also called cholecalciferol

    Vitamin D3(cholecalciferol),1600 IU per day.

  • yeast β-glucanDietary supplement

    yeast β-glucan, 600mg per day.

  • Vitamin D placeboDietary supplement

    Vitamin D placebo

  • yeast β-glucan placeboDietary supplement

    yeast β-glucan placebo

Study groups in NCT06861062
Study groupRoleWhat they receive
Vitamin D + yeast β-glucanActive comparatorNot described
Receives: Drug: Vitamin D3; Dietary Supplement: yeast β-glucan
Vitamin D + yeast β-glucan placeboActive comparatorNot described
Receives: Drug: Vitamin D3; Dietary Supplement: yeast β-glucan placebo
yeast β-glucan +Vitamin D placeboActive comparatorNot described
Receives: Dietary Supplement: yeast β-glucan; Dietary Supplement: Vitamin D placebo
Vitamin D placebo + yeast β-glucan placeboPlacebo comparatorNot described
Receives: Dietary Supplement: Vitamin D placebo; Dietary Supplement: yeast β-glucan placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control

    Change in HbA1c from baseline to the 24-month visit

    Measured: 24 months

  2. 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

    Measured: 24 months

Secondary outcomes (29)
  1. Blood 25(OH)D

    Change in blood 25(OH)D concentrations from baseline to the 24-month visit

    Measured: 24 months

  2. Major cardiovascular events

    Time to the first occurrence of any of the following: myocardial infarction, hospitalized or treated heart failure, stroke, revascularization of coronary arteries, or cardiovascular deaths

    Measured: 60 months

  3. Microvascular disease

    Time to the first occurrence of any of the following: nephropathy, retinopathy, or neuropathy

    Measured: 60 months

  4. All-cause mortality

    Deaths from any causes

    Measured: 60 months

  5. Change in fasting plasma glucose

    Change in fasting plasma glucose from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).

    Measured: 24 months

  6. Change in fasting C-peptide

    Change in fasting C-peptide from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).

    Measured: 24 months

  7. Change in insulin

    Change in insulin from baseline to the 24-month visit. The value is reported in microunit per milliliter (μU/mL).

    Measured: 24 months

  8. Change in HOMA-IR

    Change in HOMA-IR from baseline to the 24-month visit. HOMA-IR = [Fasting Serum Insulin (μU/mL) × Fasting Plasma Glucose (mmol/L)] / 22.5. Lower values indicate better insulin sensitivity.

    Measured: 24 months

  9. Change in Lipid profile

    Change in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to the 24-month visit. These values are reported in millimole per liter (mmol/L).

    Measured: 24 months

  10. Change in Liver function markers

    Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), a nd gamma-glutamyl transferase (GGT) from baseline to the 24-month visit. These values are reported in units per liter (U/L).

    Measured: 24 months

  11. Change in serum creatinine

    Change in serum creatinine from baseline to the 24-month visit. The value is reported in micromole per liter (μmol/L).

    Measured: 24 months

  12. Change in cystatin C

    Change in cystatin C from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).

    Measured: 24 months

  13. Change in eGFR

    Change in estimated glomerular filtration rate (eGFR) from baseline to the 24-month visit. The CKD-EPI (2009) method to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL/min/1.73 m²).

    Measured: 24 months

  14. Change in blood calcium

    Change in blood calcium from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).

    Measured: 24 months

  15. Change in body weight

    Change in body weight from baseline to the 24-month visit. The value is reported in kilogram (kg).

    Measured: 24 months

  16. Change in BMI

    Change in body mass index (BMI) from baseline to the 24-month visit. BMI = Body Weight (kg) / [Height (m)]^2. The value is reported in kilogram per square meter (kg/m^2).

    Measured: 24 months

  17. Change in waist circumference

    Change in waist circumference from baseline to the 24-month visit. The value is reported in centimeter (cm).

    Measured: 24 months

  18. Change in waist-to-hip ratio

    Change in waist-to-hip ratio from baseline to the 24-month visit. Waist-to-hip ratio = Waist Circumference (cm) / Hip Circumference (cm). Higher values indicate greater central adiposity.

    Measured: 24 months

  19. Change in blood pressure

    Change in systolic and diastolic blood pressure from baseline to the 24-month visit. The values are reported in millimeters of mercury (mmHg).

    Measured: 24 months

  20. Change in grip strength

    Change in grip strength from baseline to the 24-month visit, assessed using a handgrip dynamometer. The value is reported in kilogram (kg).

    Measured: 24 months

  21. Change in FRAIL scale

    FRAIL scale comprises five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5, with higher scores indicating greater frailty. Based on the total score, patients were categorized as robust (0 points), pre-frail (1-2 points), or frail (3-5 points).

    Measured: 24 months

  22. Change in C-reactive protein

    Change in C-reactive protein (CRP) from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).

    Measured: 24 months

  23. Change in procalcitonin

    Change in procalcitonin from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).

    Measured: 24 months

  24. Change in interleukin-6

    Change in interleukin-6 (IL-6) from baseline to the 24-month visit. The value is reported in picogram per milliliter (pg/mL).

    Measured: 24 months

  25. Bone mineral density

    Change in bone mineral density from baseline to the 24-month visit, including but not limited to Speed of Sound (SOS), T-score, and Z-score. SOS is reported in meters per second (m/s). T-score and Z-score have no dimensional units.

    Measured: 24 months

  26. Change in baPWV

    Change in brachial-Ankle Pulse Wave Velocity (baPWV) from baseline to the 24-month visit. The value is reported in centimeters per second (cm/s).

    Measured: 24 months

  27. Change in ABI

    Change in Ankle-Brachial Index (ABI) from baseline to the 24-month visit. ABI=Systolic blood pressure of the ankle (mmHg) / Higher values of bilateral arm systolic pressure (mmHg).

    Measured: 24 months

  28. Change in LSM

    Change in stiffness measurement (LSM) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in kilopascal (kPa).

    Measured: 24 months

  29. Change in UAP

    Change in Ultrasound Attenuation Parameter (UAP) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in Decibel per Megahertz per Centimeter (dB/MHz/cm).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start8 Apr 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06861062
Sponsor's protocol ID
VD, Yeast β-Glucan in Diabetes
Status last verified
Sep 2025
First submitted
23 Feb 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) sharing will need to be approved by the Institutional Review Board (IRB) and the study investigators with individual specific project request.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 and yeast β-glucan in people with Diabetes Mellitus, Type 2, run by Huazhong University of Science and Technology at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gang Liu, PHD (86-15926238366, liugang026@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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