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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 5
- 主要终点
- Glycemic control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vitamin D + yeast β-glucan
干预措施: Vitamin D3 (Drug)
Vitamin D + yeast β-glucan
干预措施: yeast β-glucan (Dietary Supplement)
Vitamin D + yeast β-glucan placebo
干预措施: Vitamin D3 (Drug)
Vitamin D + yeast β-glucan placebo
干预措施: yeast β-glucan placebo (Dietary Supplement)
yeast β-glucan +Vitamin D placebo
干预措施: yeast β-glucan (Dietary Supplement)
yeast β-glucan +Vitamin D placebo
干预措施: Vitamin D placebo (Dietary Supplement)
Vitamin D placebo + yeast β-glucan placebo
干预措施: Vitamin D placebo (Dietary Supplement)
Vitamin D placebo + yeast β-glucan placebo
干预措施: yeast β-glucan placebo (Dietary Supplement)
结局指标
主要结局
Glycemic control
时间窗: 24 months
Change in HbA1c from baseline to the 24-month visit
Cardiovascular disease risk
时间窗: 24 months
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
次要结局
- All-cause mortality(60 months)
- Microvascular disease(60 months)
- Blood 25(OH)D(24 months)
- Major cardiovascular events(60 months)
- Change in fasting plasma glucose(24 months)
- Change in fasting C-peptide(24 months)
- Change in insulin(24 months)
- Change in HOMA-IR(24 months)
- Change in Lipid profile(24 months)
- Change in Liver function markers(24 months)
- Change in serum creatinine(24 months)
- Change in cystatin C(24 months)
- Change in eGFR(24 months)
- Change in blood calcium(24 months)
- Change in body weight(24 months)
- Change in BMI(24 months)
- Change in waist circumference(24 months)
- Change in waist-to-hip ratio(24 months)
- Change in blood pressure(24 months)
- Change in grip strength(24 months)
- Change in FRAIL scale(24 months)
- Change in C-reactive protein(24 months)
- Change in procalcitonin(24 months)
- Change in interleukin-6(24 months)
- Bone mineral density(24 months)
- Change in baPWV(24 months)
- Change in ABI(24 months)
- Change in LSM(24 months)
- Change in UAP(24 months)
研究者
An Pan
Professor
Huazhong University of Science and Technology