Diabetes Mellitus, Type 2
Conditions
Keywords
Korean Traditional diets, hypertension, diabetes
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.
Interventions
DIETARY_SUPPLEMENTKorean 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.
DIETARY_SUPPLEMENTControl group
Told to eat as usal diets.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Valsalva score | 84days | Valsalva score is measured in study visits to the clinic, week 0(baseline)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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body fat percent | 84days | Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. |
| Waist | 84days | Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. |
| Obesity associated gut microbiome(Bacteriodetes) | 84days | Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12. |
| Obesity associated gut microbiome(Firmicutes) | 84days | Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12. |
| Hypoglycemic(oral medication) | 84days | Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk. |
| Control blood pressure(oral medication) | 84days | Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk. |
| Lipid modifying (oral medication) | 84days | Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk. |
| BMI:Body Mass Index | 84days | BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. |
| weight | 84days | weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12. |
Countries
South Korea
Outcome results
None listed