The Assessment of the Effect of Vitamin D Supplementation on the Serum of AGES and Endothelialy Factors and Gene Expression of Glyoxalase Enzyme and YKL-40 Factor in PBMC Cells in the Patients With Type 2 Diabetes .
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 主要终点
- serum HbA1c
研究概览
简要总结
The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2 patients.
详细描述
The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the gene expression of plasma human cartilage glycoprotein 39(YKL40), receptor for advanced glycation end products (RAGE) and glyoxalase enzyme in the peripheral blood mononuclear cell (PBMC) and serum levels of YKL40 ,plasminogen activator inhibitor-1 (PAI-1), TNF-α, advanced glycation end products (AGEs ), IL-6, and HbA1c of diabetes type 2 patients.
In this randomized, double-blind clinical trial, placebo-controlled study, 84 women and men with type 2 diabetes are enrolled from the Iranian Center of diabetes. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food record for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 2 groups: 1) receiving vitamin D supplement 2) receiving vitamin D placebo bo.
The vitamin D supplement group will receive 4000 IU (100 microgram) daily for 3 months. The vitamin D placebo group will also receive placebo containing starch both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30 ,literate, willingness to participation,avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -
排除标准
- •people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers,sever change in regular diet and life style,change in type and dosage of regular medication (s)
结局指标
主要结局
serum HbA1c
时间窗: Change frome baseline at 3 months
serum fasting insulin
时间窗: Change frome baseline at 3 months
serum Fasting blood suger,
时间窗: Change frome baseline at 3 months
次要结局
- RAGE gene expression(Change frome baseline at 3 months)
- YKL40 gene expression(Change frome baseline at 3 months)
- serum AGES(Change frome baseline at 3 months)
- serum IL6(Change frome baseline at 3 months)
- serum TNF-alpha(Change frome baseline at 3 months)
- serum PAI-1(Change frome baseline at 3 months)
- glyoxalase enzyme gene expression(Change frome baseline at 3 months)
- serum YKL40(Change frome baseline at 3 months)
- serum IL-17(Change frome baseline at 3 months)
- Serum IL-4(Change frome baseline at 3 months)
- serum Transforming growth factor beta(Change frome baseline at 3 months)