Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
2012年11月9日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jeollabuk-do
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Jeonju、Jeollabuk-do、大韓民国、560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
19年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：Control group
Control group : told to "eat as usal diet) for 12weeks
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Told to " eat as usal diets".
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HbA1C :Glycated Hemoglobin
時間枠：84days
|
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
TG :Triglycerides
時間枠：84days
|
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
TC :Total cholesterol
時間枠：84days
|
Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
HDL-C :High Density Lipoprotein-Cholesterol
時間枠：84days
|
HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
LDL-C : Low Density Lipoprotein-Cholesterol
時間枠：84days
|
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Breathing score
時間枠：84days
|
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
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Valsalva score
時間枠：84days
|
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
|
Upright score
時間枠：84days
|
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
|
84days
|
|
ApoA1 :Apolipoprotein A1
時間枠：84days
|
Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
ApoB :Apolipoprotein B
時間枠：84days
|
Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Apo E :Apolipoprotein E
時間枠：84days
|
Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Free fatty acid
時間枠：84days
|
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Adiponectin
時間枠：84days
|
Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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PAI-1 :Plasminogen activator inhibitor type 1
時間枠：84days
|
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Homocysteine
時間枠：84days
|
Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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FPG :Fasting plasma glucose
時間枠：84days
|
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
時間枠：84days
|
DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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SBP:Systolic Blood Pressure
時間枠：84days
|
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Heart rate
時間枠：84days
|
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
weight
時間枠：84days
|
weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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BMI:Body Mass Index
時間枠：84days
|
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Body fat percent
時間枠：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.
|
84days
|
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Waist
時間枠：84days
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Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Obesity associated gut microbiome(Bacteriodetes)
時間枠：84days
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Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
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Obesity associated gut microbiome(Firmicutes)
時間枠：84days
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Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
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Hypoglycemic(oral medication)
時間枠：84days
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Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
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Control blood pressure(oral medication)
時間枠：84days
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Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
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Lipid modifying (oral medication)
時間枠：84days
|
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年9月1日
一次修了 (実際)
2011年1月1日
研究の完了 (実際)
2011年2月1日
試験登録日
最初に提出
2012年10月29日
QC基準を満たした最初の提出物
2012年11月9日
最初の投稿 (見積もり)
2012年11月12日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年11月12日
QC基準を満たした最後の更新が送信されました
2012年11月9日
最終確認日
2012年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。