Clinical trial NCT01724645: Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
Official title: Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Korean Traditional diets
hypertension
diabetes
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1C :Glycated Hemoglobin
timeFrame: 84days
Secondary outcomes:
measure: TG :Triglycerides
timeFrame: 84days
measure: TC :Total cholesterol
timeFrame: 84days
measure: HDL-C :High Density Lipoprotein-Cholesterol
timeFrame: 84days
measure: LDL-C : Low Density Lipoprotein-Cholesterol
timeFrame: 84days
measure: Breathing score
timeFrame: 84days
measure: Valsalva score
timeFrame: 84days
measure: Upright score
timeFrame: 84days
measure: ApoA1 :Apolipoprotein A1
timeFrame: 84days
measure: ApoB :Apolipoprotein B
timeFrame: 84days
measure: Apo E :Apolipoprotein E
timeFrame: 84days
measure: Free fatty acid
timeFrame: 84days
measure: Adiponectin
timeFrame: 84days
measure: PAI-1 :Plasminogen activator inhibitor type 1
timeFrame: 84days
measure: Homocysteine
timeFrame: 84days
measure: FPG :Fasting plasma glucose
timeFrame: 84days
measure: DBP:Diastolic Blood Pressure
timeFrame: 84days
measure: SBP:Systolic Blood Pressure
timeFrame: 84days
measure: Heart rate
timeFrame: 84days
Other outcomes:
measure: weight
timeFrame: 84days
measure: BMI:Body Mass Index
timeFrame: 84days
measure: Body fat percent
timeFrame: 84days
measure: Waist
timeFrame: 84days
measure: Obesity associated gut microbiome(Bacteriodetes)
timeFrame: 84days
measure: Obesity associated gut microbiome(Firmicutes)
timeFrame: 84days
measure: Hypoglycemic(oral medication)
timeFrame: 84days
measure: Control blood pressure(oral medication)
timeFrame: 84days
measure: Lipid modifying (oral medication)
timeFrame: 84days
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Soo-Wan Chae, MD., PhD
role: STUDY_DIRECTOR
References: