The Effect of Oral Calcium Supplementation on Insulin Sensitivity, Intracellular Cationic Concentrations and the Transmembrane Sodium/Hydrogen Exchanger Activity in Subjects With Type 2 Diabetes and Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group.
研究概览
简要总结
Increased levels of intracellular calcium are thought to diminish maximal cellular response to insulin and induce insulin resistance. Also, both hypertension and diabetes are thought to be conditions of altered intracellular ionic state. The aim of the present study is to investigate the possible effect of oral calcium supplementation on intracellular ions, insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients with type 2 diabetes and essential hypertension.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypertension, diabetes and the metabolic syndrome (according to the definition of the National Cholesterol Education Program, Adult Panel III (NCEP, ATP III).
- •Signed the concent form
排除标准
- •Secondary Hypertension
- •Stage II or III hypertension
- •History of renal disease
- •Sleep apnea
- •Acute or chronic inflammation
- •History of coronary artery disease
- •Heart failure stage III or IV according to the New York Heart Association
- •Active liver disease
- •History of malignancy
- •Parathyroidism
- •History of kidney stones
- •Calcium supplement ingestion
- •Drugs that alter insulin resistance
- •Treatment with insulin
- •Alcohol abuse or other conditions with poor prognosis
- •Treatment with non-inflammatory steroid agents, corticosteroids, or any other treatment that affects blood pressure
研究组 & 干预措施
2
干预措施: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) (Dietary Supplement)
1
Patients on calcium supplementation
干预措施: tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz) (Dietary Supplement)
结局指标
主要结局
To evaluate the difference in 24h blood pressure measurement and insulin sensitivity between the treatment and the control group.
时间窗: baseline and after 8 weeks of follow up
次要结局
- To evaluate differences in intracellular calcium, magnesium, sodium and potassium concentrations at the end of the follow up period between the calcium supplementation group and the control group.(baseline and after 8 weeks of follow up)
- To evaluate differences in the transmembrane sodium/hydrogen exchanger activity between the active treatment and the control group.(baseline and after 8 weeks of follow up)