Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change from Baseline fasting blood glucose (FBG) at 6 months
研究概览
简要总结
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
详细描述
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.
入排标准
- 年龄范围
- 60 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects deficient in vitamin D
- •Subjects having type 2 diabetes
- •Non-obese subjects
排除标准
- •Subjects having hyperparathyroidism
- •Subjects suffering from hepatic disease / kidney disease
研究组 & 干预措施
treatment group
Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months.
干预措施: cholecalciferol (Euro-Pharm International, Canada) (Dietary Supplement)
Placebo group
Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
干预措施: Placebo tablet (Dietary Supplement)
结局指标
主要结局
Change from Baseline fasting blood glucose (FBG) at 6 months
时间窗: baseline and after 6 months of intervention
FASTING BLOOD GLUCOSE
Change from Baseline C-reactive protein (CRP) at 6 months
时间窗: baseline and after 6 months of intervention
C-reactive protein
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
时间窗: baseline and after 6 months of intervention
Homeostatic Model Assessment of Insulin Resistance
Change from Baseline Interleukin-6 (IL-6) at 6 months
时间窗: baseline and after 6 months of intervention
Interleukin-6
Change from Baseline TNF-alpha at 6 months
时间窗: baseline and after 6 months of intervention
TNF-alpha
次要结局
- Change from Baseline weight at 6 months(baseline and after 6 months of intervention)
- Change from Baseline Body Mass Index (BMI) at 6 months(baseline and after 6 months of intervention)
- Change from Baseline waist circumference at 6 months(baseline and after 6 months of intervention)
- Change from Baseline Parathyroid hormone (PTH) at 6 months(baseline and after 6 months of intervention)
- Change from Baseline Percentage of fat at 6 months(baseline and after 6 months of intervention)