Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
2012년 11월 9일 업데이트: Soo-Wan Chae, Chonbuk National University Hospital
Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Jeollabuk-do
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Jeonju, Jeollabuk-do, 대한민국, 560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
19년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
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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.
다른 이름들:
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활성 비교기: Control group
Control group : told to "eat as usal diet) for 12weeks
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Told to " eat as usal diets".
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HbA1C :Glycated Hemoglobin
기간: 84days
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Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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TG :Triglycerides
기간: 84days
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Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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TC :Total cholesterol
기간: 84days
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Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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HDL-C :High Density Lipoprotein-Cholesterol
기간: 84days
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HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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LDL-C : Low Density Lipoprotein-Cholesterol
기간: 84days
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LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Breathing score
기간: 84days
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Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Valsalva score
기간: 84days
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Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Upright score
기간: 84days
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Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
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84days
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ApoA1 :Apolipoprotein A1
기간: 84days
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Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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ApoB :Apolipoprotein B
기간: 84days
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Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Apo E :Apolipoprotein E
기간: 84days
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Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Free fatty acid
기간: 84days
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Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Adiponectin
기간: 84days
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Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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PAI-1 :Plasminogen activator inhibitor type 1
기간: 84days
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PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Homocysteine
기간: 84days
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Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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FPG :Fasting plasma glucose
기간: 84days
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Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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DBP:Diastolic Blood Pressure
기간: 84days
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DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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SBP:Systolic Blood Pressure
기간: 84days
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SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Heart rate
기간: 84days
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Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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weight
기간: 84days
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weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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BMI:Body Mass Index
기간: 84days
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BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Body fat percent
기간: 84days
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Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Waist
기간: 84days
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Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Obesity associated gut microbiome(Bacteriodetes)
기간: 84days
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Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Obesity associated gut microbiome(Firmicutes)
기간: 84days
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Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
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Hypoglycemic(oral medication)
기간: 84days
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Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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Control blood pressure(oral medication)
기간: 84days
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Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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Lipid modifying (oral medication)
기간: 84days
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Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 9월 1일
기본 완료 (실제)
2011년 1월 1일
연구 완료 (실제)
2011년 2월 1일
연구 등록 날짜
최초 제출
2012년 10월 29일
QC 기준을 충족하는 최초 제출
2012년 11월 9일
처음 게시됨 (추정)
2012년 11월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 11월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 9일
마지막으로 확인됨
2012년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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