Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Primary Outcome: Reduction of total and LDL cholesterol
研究概览
简要总结
Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals.
Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery.
Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy.
Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.
详细描述
Introduction: The consumption of a dietary portfolio has been found to successfully reduce LDL cholesterol by 30% in hyperlipidemic, non-diabetic patients under highly controlled conditions. Given the burden of cardiovascular disease in the diabetic population, it is now important that we evaluate whether consumption of the dietary portfolio can reduce modifiable risk factors and improve diabetic control above that associated with medical therapy alone in this population. The reduction of modifiable risk factors, particularly in the diabetic patient with coronary artery disease, should not only improve long-term outcomes thereby reducing re-admissions and subsequently the burden of the diabetic patient on the health care system, but also improve quality of life for these patients. This pilot project will determine the efficacy, feasibility and tolerability of an aggressive dietary strategy, the dietary portfolio of functional foods to reduce cardiovascular risk factors in diabetic patients following CABG.
Study Objectives: This study will determine to what extent the self selected "modified" dietary portfolio (without sterols) together with statin therapy will:
- reduce total and LDL cholesterol
- increase endothelial cell number and function and reduce CRP levels.
- reduce markers of inflammation and insulin resistance
- the study will also determine the tolerability of and compliance with the portfolio diet
Primary Hypothesis: The consumption of the modified dietary portfolio will have a pleiotropic effect with current statin therapy resulting in an additional reduction in LDL cholesterol of 25% after four weeks of treatment.
Secondary Hypotheses: The addition of the dietary portfolio together with statin therapy will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type II diabetes mellitus
- •Recently (<5 months) undergone coronary artery bypass graft surgery
- •Taking cholesterol lowering medication
排除标准
- •Can not speak English and have no available interpreter
- •Refuse Informed Consent
- •Had "off pump" CABG
- •Are intolerant of statins
- •Are pre-menopausal (women) or are on HRT
- •Have serious concomitant disease
- •Take insulin
- •Are <18 years of age
- •receive incomplete revascularization
- •documented history of drug or alcohol abuse
- •Intend to become pregnant during study period
- •Have an unreliable psychological condition that makes them unlikely to comply
结局指标
主要结局
Primary Outcome: Reduction of total and LDL cholesterol
时间窗: baseline to 4 weeks
次要结局
- Improvement in endothelial function and EPC counts(Baseline to 4 weeks)
- Reduction in CRP(baseline to 4 weeks)
- Feasibility and tolerability(Baseline to 4 Weeks)
- Reduction in markers of inflammation ie TNF, IL-6(Baseline to 4 weeks)
- Improved markers of glycemic control - fructosamine, HOMA(baseline to 4 weeks)