Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Renin production by monocytes
研究概览
简要总结
This trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs. sufficiency will induce hormones that increase blood pressure.
详细描述
More than half of patients with type 2 diabetes mellitus develop hypertension, which doubles their risk for cardiovascular disease. Inflammation plays a role in the development of these diseases, and monocytes, a type of white blood cell, may be critical. This study will isolate monocytes from blood samples of patients with type 2 diabetes and high blood pressure who have either high levels of vitamin D or low levels of vitamin D, and determine what their effects are on stimulating production in kidney cells of a hormone that increases blood pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (T2DM)
- •Age: 25-80 years old
- •Vitamin 25(OH)D3 levels <20 or >30 ng/ml.
- •HbA1c: 5.5%-9.5%
- •Blood Pressure: <160/100 mm Hg on BP lowering medications and
- •Blood Pressure: >120/80 to 160/100 mmHg without BP lowering medications
排除标准
- •Recent weight loss of more than 5% within 3 months prior to screening
- •Current Pregnancy
- •Hypercalcemia
- •Previous heart attack and stroke
- •Heart failure
- •Atrial fibrillation
- •Heavy alcohol consumption
- •Extreme diets (Atkins, South Beach)
- •Chronic renal failure: stage 4 or worse
- •>2 + proteinuria on urine sample
- •Chronic diseases known to affect immunity
结局指标
主要结局
Renin production by monocytes
时间窗: 2 weeks
Blood will be collected for isolation of monocytes. These cells will then be cultured to determine whether there is monocyte stimulation of a hormone that induces high blood pressure (renin) in kidney cells.
次要结局
- Renin production by monocyte media(2 weeks)