Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Korean traditional diets
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean traditional diets<br>Korean traditional diets (calorie 2,100kcal) for 12weeks | Dietary Supplement: Korean traditional diets<br>* 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.<br>* Other names: The Korean Traditonal diets;|
| Active Comparator: Control group<br>Control group : told to eat as usal diet) for 12weeks | Dietary Supplement: Control group<br>* Told to  eat as usal diets.<br>* Other names: Control diets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C :Glycated Hemoglobin | Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TG :Triglycerides | Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| TC :Total cholesterol | Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| HDL-C :High Density Lipoprotein-Cholesterol | HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| LDL-C : Low Density Lipoprotein-Cholesterol | LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Breathing score | Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12. | 84days | 
| Valsalva score | Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12. | 84days | 
| Upright score | Upright score is measured in study visits to the clinic, week 0(baseline) and week 12. | 84days | 
| ApoA1 :Apolipoprotein A1 | Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| ApoB :Apolipoprotein B | Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Apo E :Apolipoprotein E | Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Free fatty acid | Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Adiponectin | Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| PAI-1 :Plasminogen activator inhibitor type 1 | PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Homocysteine | Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| FPG :Fasting plasma glucose | Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| DBP:Diastolic Blood Pressure | DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| SBP:Systolic Blood Pressure | SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 
| Heart rate | Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. | 84days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean Traditional diets, hypertension, diabetes