NCT00677599已完成不适用
Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples .
研究概览
简要总结
The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having had a natural menopause and a minimum of 1 year since last menstruation
- •Caucasian
- •under 70 years
- •Type 2 diabetics
- •Those using statins (≥40 mg simvastatin or ≥10 mg atorvastatin) for at least 12 months
- •Not currently taking Hormone Replacement Therapy (HRT) and not having taken HRT for a minimum of 6 months prior to commencement
- •Having no significant past or present medical history of vascular disease, or cancers (specifically breast, uterine or ovarian)
- •Never-smokers, and ex-smokers who have given up smoking at least 12 months before recruitment to the study
排除标准
- •Currently taking HRT or having taken this medication within 6 months of the trial
- •Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
- •Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
- •Current smokers or those having given up smoking less than 12 months before recruitment to the study
- •Those prescribed aspirin for a period of less than 12 months prior to recruitment
- •Those prescribed insulin for a period of less than 12 months prior to recruitment and those having had increases to their medication indicating poor control
- •Regular non-prescribed use of anti-inflammatory pain relief medication (i.e. aspirin, paracetamol, cocodamol).
- •Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
- •Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
- •Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
- •Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
- •Assessed from the clinical screening: HbA1c ≥ 10%; Creatinine >125µmol/L; ALP > 378 IU/L; ALT >150 IU/L; GGT > 180 IU/L
研究组 & 干预措施
Intervention B
Placebo Comparator
干预措施: Flavonoid enrichment (cocoa / soy compounds) (Dietary Supplement)
Intervention A
Active Comparator
Experimental arm enriched with flavonoids
干预措施: Flavonoid enrichment (cocoa / soy compounds) (Dietary Supplement)
结局指标
主要结局
Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples .
时间窗: 6 months - 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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