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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724645
• Other study ID #: CUH_KOREAN-FOOD_2-2_2010
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: November 9, 2012
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Dietary Supplement:
• Korean traditional diets
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.
• Control group
Told to " eat as usal diets".

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	weight	weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Other	BMI:Body Mass Index	BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Other	Body fat percent	Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Other	Waist	Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Other	Obesity associated gut microbiome(Bacteriodetes)	Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Other	Obesity associated gut microbiome(Firmicutes)	Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Other	Hypoglycemic(oral medication)	Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.	84days
Other	Control blood pressure(oral medication)	Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.	84days
Other	Lipid modifying (oral medication)	Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.	84days
Primary	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	TG :Triglycerides	Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	TC :Total cholesterol	Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	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
Secondary	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
Secondary	Breathing score	Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Secondary	Valsalva score	Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Secondary	Upright score	Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.	84days
Secondary	ApoA1 :Apolipoprotein A1	Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	ApoB :Apolipoprotein B	Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	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
Secondary	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
Secondary	Adiponectin	Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	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
Secondary	Homocysteine	Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	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
Secondary	DBP:Diastolic Blood Pressure	DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	SBP:Systolic Blood Pressure	SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Secondary	Heart rate	Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days