The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Percentage Change in HOMA-IR
研究概览
简要总结
Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.
详细描述
Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women aged 30-70 y
- •Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l
排除标准
- •Diabetes renal diseases
- •Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
- •Medications affecting glucose or lipid metabolism
结局指标
主要结局
Percentage Change in HOMA-IR
时间窗: Baseline, 6 months
HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value\*100%
Percentage Change in Fasting Plasma Glucose
时间窗: Baseline,6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in 120-minutes Postload Plasma Glucose
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline\*100%
Percentage Change in HbA1C
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in AUC of Glucose
时间窗: Baseline, 6 months
values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value\*100%
Percentage Change in Fasting Plasma Insulin
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in QUICKI
时间窗: Baseline, 6 months
QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value\*100%
Percentage Change in Total Cholesterol
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in Triglyceride
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in High Density Lipoprotein Cholesterol
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
Percentage Change in Low Density Lipoprotein Cholesterol
时间窗: Baseline, 6 months
(6th month value-baseline value)/baseline value\*100%
次要结局
- Total Urinary Isoflavones(3 months)
- Urinary Daidzein(3 months)
- Urinary Genistein(3 months)
- Total Energy Intake at Follow-up(an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.)
研究者
yanbinye
Associate professor
Sun Yat-sen University