Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
2012年11月9日 更新者：Soo-Wan Chae、Chonbuk National University Hospital
Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.
This trial is being conducted to look for following changes when Korean traditional diets is taken in subjects with hypertension and type 2 diabetes:
To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.
To assess the controlling blood pressure and heart rate.
To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.
To evaluate the influence on Gamma-Glutamyl Transpeptidase.
To evaluate the influence on Cardiovascular risk factor.
To evaluate the influence on valsava score, breathing score and upright score.
研究概览
详细说明
The investigators aimed to investigate the efficacy of Korean traditional diets in controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk factors in hypertensive and type 2 diabetic patients who were taking medications prescribed for respective diseases in a 12-week.
研究类型
介入性
注册 (实际的)
48
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jeollabuk-do
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Jeonju、Jeollabuk-do、大韩民国、560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects who are men and women volunteers 19~80years
- Subject who have hypertension and type 2diabetes.
- Subject who have taking oral medications :
(hypoglycemic, blood pressure and lipid modifying drugs).
- Subject must provide written informed consent to participate in the study.
Exclusion Criteria:
- Subject with a history or evidence of clinically significant gastrointestinal,anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor,psychiatric.
- Hypertension(DBP>116mmHg or SBP>200 mmHg) having the history of cardiovascular events or taking medications known to affect lipoprotein metabolism.
- Having Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (HbA1c >9.0%).
- Subjects with the history of cancer.
- Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery.
- Having digestive, or central nervous system disorders.
- Subject is hematologic, or neuroretinopathy.
- Subject with uterine fibroids at ultrasonography.
- Having severe or malignant retinopathy.
- Having the impairment of renal and liver function, dysproteinemia, nephritic syndrome, or other renal disease.
- Having coagulopathy
- Having human immunodeficiency virus.
- Having the history of mental instability and of drug and alcohol.
- Having the history of reactions to our experimental products.
- Participating in other clinical trials within the past 2 months.
- Having laboratory tests, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study.
- Having the history of alcohol or substance abuse.
- Subject is pregnant, planning to become pregnant, or breast-feeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
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The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely. The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.
其他名称：
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有源比较器：Control group
Control group : told to "eat as usal diet) for 12weeks
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Told to " eat as usal diets".
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HbA1C :Glycated Hemoglobin
大体时间：84days
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Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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TG :Triglycerides
大体时间：84days
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Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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TC :Total cholesterol
大体时间：84days
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Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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HDL-C :High Density Lipoprotein-Cholesterol
大体时间：84days
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HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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LDL-C : Low Density Lipoprotein-Cholesterol
大体时间：84days
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LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Breathing score
大体时间：84days
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Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Valsalva score
大体时间：84days
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Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Upright score
大体时间：84days
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Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
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84days
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ApoA1 :Apolipoprotein A1
大体时间：84days
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Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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ApoB :Apolipoprotein B
大体时间：84days
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Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Apo E :Apolipoprotein E
大体时间：84days
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Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Free fatty acid
大体时间：84days
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Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Adiponectin
大体时间：84days
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Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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PAI-1 :Plasminogen activator inhibitor type 1
大体时间：84days
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PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Homocysteine
大体时间：84days
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Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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FPG :Fasting plasma glucose
大体时间：84days
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Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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DBP:Diastolic Blood Pressure
大体时间：84days
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DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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SBP:Systolic Blood Pressure
大体时间：84days
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SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Heart rate
大体时间：84days
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Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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weight
大体时间：84days
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weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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BMI:Body Mass Index
大体时间：84days
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BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Body fat percent
大体时间：84days
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Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Waist
大体时间：84days
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Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Obesity associated gut microbiome(Bacteriodetes)
大体时间：84days
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Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Obesity associated gut microbiome(Firmicutes)
大体时间：84days
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Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Hypoglycemic(oral medication)
大体时间：84days
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Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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Control blood pressure(oral medication)
大体时间：84days
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Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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Lipid modifying (oral medication)
大体时间：84days
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Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年9月1日
初级完成 (实际的)
2011年1月1日
研究完成 (实际的)
2011年2月1日
研究注册日期
首次提交
2012年10月29日
首先提交符合 QC 标准的
2012年11月9日
首次发布 (估计)
2012年11月12日
研究记录更新
最后更新发布 (估计)
2012年11月12日
上次提交的符合 QC 标准的更新
2012年11月9日
最后验证
2012年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.