Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- HbA1C :Glycated Hemoglobin
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Intervention: Korean traditional diets (Dietary Supplement)
Control group
Control group : told to "eat as usal diet) for 12weeks
Intervention: Control group (Dietary Supplement)
Outcomes
Primary Outcomes
HbA1C :Glycated Hemoglobin
Time Frame: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
Secondary Outcomes
- 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)
- Free fatty acid(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)
Investigators
Soo-Wan Chae
director
Chonbuk National University Hospital