Effect of Vitamin D Supplementation on Myocardial Regional Function by Dobutamine Stress Echocardiography in Diabetic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in longitudinal strain
研究概览
简要总结
Vitamin D deficiency is recognized as a cardiovascular risk factor. Diabetic patients are of major risk for cardiovascular diseases and typically present with Vitamin D deficiencies. Myocardial function is altered in both type I and II diabetic patients but no data is today available on the effect of Vitamin D supplementation.
The aim of the study will be to investigate myocardial function (by deformation imaging techniques) at rest and during low-dose dobutamine stress echocardiography in both type I and II diabetic patients. Within each diabetic population, myocardial function will be compared at baseline between the vitamin D deficient and non-deficient individuals. Furthermore, the investigators will study the effect of a 3 month supplementation in those with deficiencies.
详细描述
Rationale:
Vitamin D exerts a principal role in homeostasis of calcium and phosphorus. However, recent studies indicated also its important function in cell differentiation, proliferation and growth as well as regulation of the immune system.
Vitamin Deficiency is today recognized as a risk factor for cardiovascular disease (CVD). Diabetic patients are of major risk for CVD. They typically present with Vitamin D deficiencies. Experimental studies have established as a result of Vitamin D deficiency alterations in intrinsic cardiac contractile and relaxation properties, hypertrophy and fibrosis. Regional myocardial function is altered in both type I and II diabetic patients. In type II diabetic individuals, myocardial dysfunction is furthermore exacerbated in those with Vitamin D deficiency compared to those with normal levels. In patients free from CV risk and deficient in Vitamin D, regional myocardial function improved after Vitamin D supplementation. To the best of our knowledge, no scientific study is today available on the effect of Vitamin D supplementation on regional myocardial function in diabetic patients deficient in vitamin D.
Objectives and Methodology:
- To compare regional myocardial linear deformation and torsion, at rest and in response to a DB stress in diabetic patients deficient and non-deficient in Vitamin D.
- To evaluate the impact of vitamin D supplementation in those with vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-masked study. Clinicians and researchers in charge of main outcomes (eg cardiac remodelling and global function, regional myocardial function) measurements will not be aware of group allocation (eg vitamin D deficient and non-deficient sub-groups) and time study (eg baseline or post vitamin D supplementation).
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 40-65 years old, asymptomatic and free from epicardial coronary artery disease.
排除标准
- •body mass index > 35 kg / m2, defining severe obesity,
- •Under insulin therapy (for Type II only)
- •Poorly controlled hypertension (> 140/95)
- •LV ejection fraction (LVEF) < 55%
- •Peripheral vascular disease (> stage II of Leriche)
- •Heart disease or known coronary artery disease,
- •Known and poorly compensated thyroid dysfunction,
- •Nocturnal apnea syndrome,
- •Inability to give written informed consent,
- •Chronic diseases,
- •moderate to severe left ventricular hypertrophy :> 109 g / m2 in women and> 132 g / m2 in men and parietal thickness > 13mm.
- •poor glycemic control (HbA1c > 9%)
- •poor echogenicity
- •severe autonomic or peripheral neuropathy,
- •Severe diabetic retinopathy,
- •Advanced Diabetic nephropathy (defined by documented proteinuria and/or renal failure).
结局指标
主要结局
Change in longitudinal strain
时间窗: Before and after 3 month of Vitamin D supplementation
Index of myocardial function measured using deformation imaging technique by echocardiography, at rest and under dobutamine stress.
次要结局
未报告次要终点