NCT06861062 Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes
| NCT ID | NCT06861062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2025-04-08 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 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); 2. Men or women aged 40-79 years; 3. Convenient access to the study centers and permanent residence in the vicinity for the next five years; 4. Voluntary participation and signed written informed consent. Exclusion Criteria: 1. History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary revascularization) within the past 6 months; 2. 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); 3. History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis; 4. History of kidney stones, hypercalcemia, or hyperparathyroidism; 5. 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; 6. 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); 7. 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; 8. Participation in other clinical trials within the past 3 months; 9. Planning to become pregnant within the next five years, or currently pregnant or breastfeeding.
Contact & Investigator
An Pan, PHD
PRINCIPAL INVESTIGATOR
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06861062 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 79 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06861062 currently recruiting?
Yes, NCT06861062 is actively recruiting participants. Contact the research team at liugang026@hust.edu.cn for enrollment information.
Where is the NCT06861062 trial being conducted?
This trial is being conducted at Nanning, China, Tangshan, China, Shiyan, China, Wuhan, China and 1 additional location.
Who is sponsoring the NCT06861062 clinical trial?
NCT06861062 is sponsored by Huazhong University of Science and Technology. The principal investigator is An Pan, PHD at School of Public Health, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 2,500 participants.
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