Vitamin C Therapy in Type 2 Diabetes and Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- To determine the optimal oral dose of vitamin C and E to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals.
研究概览
简要总结
Study Goal #1: Determine the optimal oral dose of vitamin C to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals.
Study Goal #2: After conducting the original study, we found that vitamin E was not effective in reducing the markers of oxidative stress, hypercoagulation, inflammation, and metabolic parameters in patients with type 2 diabetes.
To date, data from randomized trials have largely demonstrated no significant benefit of vitamin E supplementation on the prevention of primary and/or secondary cardiovascular disease as once thought. Therefore, we decided to amend our current protocol to add a Part B to study only the effects of vitamin C at the following doses: 500 mg, 1000 mg, and 2000 mg daily (and include a placebo arm, as well.
详细描述
More than 70% of type 2 diabetic individuals will die of atherosclerotic disease (1). This is partially explained by the abnormal lipid profile frequently observed in type 2 diabetes. These patients are also frequently afflicted with "Syndrome X," an assortment of risk factors for atherosclerosis, including hypertension, abdominal obesity, hyperuricemia, prothrombotic and proinflammatory states, and increased plasminogen activator inhibitor type I (PAI-1) (2).
Several approaches have been suggested to reduce the risk of atherosclerosis in type 2 diabetic individuals. Changes in lifestyle leading to increased exercise and weight loss will result in the reduction of adipose stores (and restore tissue sensitivity to insulin). However, this approach is very difficult for many individuals to achieve. For them, this can be supplemented with medications such as aspirin, angiotensin inhibitors, angiotensin receptor blockers, and the statins. Unfortunately, each of these medications is either expensive and/or includes undesirable side effects (3). In addition, clinical experience shows that many patients are against taking medication for cultural reasons and/or fear of long-term unknown consequences.
For these reasons, there is great interest in using vitamins to reduce atherogenic risk. More than half of the U.S. adult population consumes vitamins on a regular basis. They are inexpensive and easily accessible in grocery stores and health food stores. The FDA does not consider them as "drugs" and they undergo a less rigorous approval procedure (4,5). Vitamins are natural compounds found in the body, and many individuals do not consider them drugs, but feel they are simply fortifying their bodies against disease.
There is currently a focus on vitamins that are antioxidants, including vitamin C. Patients with diabetes usually have a decreased antioxidant status, which leads to increased oxidative stress and vascular dysfunction (6,7). Oxidative stress refers to the excessive production of oxygen free radical species, which damage their surrounding molecules, and this leads to the increased release of inflammatory mediators, oxidation of low-density lipoproteins (LDL), and increased coagulation (7).
Vitamin C, another antioxidant, has been shown to regenerate Vitamin E, and in patients with increased oxidative stress (i.e. patients with conditions such as diabetes mellitus, coronary artery disease, and hypercholesterolemia), it restores endothelium-dependent artery vasodilation, and may reverse endothelial dysfunction in peripheral arteries (6). It has been hypothesized that supplementation of vitamin C may be more effective than vitamins taken together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic for at lease 6 months
- •Body mass index less than 40kg/m2
- •Normal EEG's
- •Normal test results from screening visit.
排除标准
- •Known vascular disease
- •Uncontrolled hypertension (>140/90 mmHg) or marked hyperlipidemia (serum low denisity lipoprotein >4.1 mmol/L or serum triglycerides > 7.8 mmol/L)
- •Pregnancy
- •Cigarette smoking
- •Currently taking coumadin
- •Recent use of antioxidant supplements or asprin.
结局指标
主要结局
To determine the optimal oral dose of vitamin C and E to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals.
时间窗: 8 weeks
次要结局
- To study the effects of vitamin C on fibrinogen, insulin, glucose, PAI-1, adiponectin, free MDA, Oxy LDL,CRP, cholesterol, and FFA.(8 weeks)
