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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Korean traditional diets; Dietary Supplement: Control group

• Registration Number: NCT01724645
• Lead Sponsor: Chonbuk National University Hospital

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Study First Submitted: 2012-10-29
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-09
• Last Update Submitted: 2012-11-09
• Study First Posted: 2012-11-12
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korean traditional diets	Korean traditional diets	Korean traditional diets (calorie 2,100kcal) for 12weeks
Control group	Control group	Control group : told to "eat as usal diet) for 12weeks

Primary Outcome Measures

Name	Time	Method
HbA1C :Glycated Hemoglobin	84days	Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of