Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- HbA1C :Glycated Hemoglobin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HbA1C :Glycated Hemoglobin
时间窗: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
次要结局
- Free fatty acid(84days)
- TG :Triglycerides(84days)
- TC :Total cholesterol(84days)
- HDL-C :High Density Lipoprotein-Cholesterol(84days)
- LDL-C : Low Density Lipoprotein-Cholesterol(84days)
- Breathing score(84days)
- Valsalva score(84days)
- Upright score(84days)
- ApoA1 :Apolipoprotein A1(84days)
- ApoB :Apolipoprotein B(84days)
- Apo E :Apolipoprotein E(84days)
- Adiponectin(84days)
- PAI-1 :Plasminogen activator inhibitor type 1(84days)
- Homocysteine(84days)
- FPG :Fasting plasma glucose(84days)
- DBP:Diastolic Blood Pressure(84days)
- SBP:Systolic Blood Pressure(84days)
- Heart rate(84days)
研究者
Soo-Wan Chae
director
Chonbuk National University Hospital