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

Chonbuk National University

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Dietary Supplement: Control group

Dietary Supplement: Korean traditional diets

Study type

Interventional

Funder types

Other

Identifiers

NCT01724645

CUH_KOREAN-FOOD_2-2_2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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.