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

9 novembre 2012 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Corée, République de
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Corée, République de, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

19 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Complément alimentaire: 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.

Autres noms:
  • The Korean Traditonal diets
Comparateur actif: Control group
Control group : told to "eat as usal diet) for 12weeks
Complément alimentaire: Control group
Told to " eat as usal diets".
Autres noms:
  • Control diets

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
HbA1C :Glycated Hemoglobin
Délai: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
TG :Triglycerides
Délai: 84days
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
TC :Total cholesterol
Délai: 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
Délai: 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
Délai: 84days
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Breathing score
Délai: 84days
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Valsalva score
Délai: 84days
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Upright score
Délai: 84days
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
84days
ApoA1 :Apolipoprotein A1
Délai: 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
Délai: 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
Délai: 84days
Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Free fatty acid
Délai: 84days
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Adiponectin
Délai: 84days
Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
PAI-1 :Plasminogen activator inhibitor type 1
Délai: 84days
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Homocysteine
Délai: 84days
Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
FPG :Fasting plasma glucose
Délai: 84days
Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
DBP:Diastolic Blood Pressure
Délai: 84days
DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
SBP:Systolic Blood Pressure
Délai: 84days
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Heart rate
Délai: 84days
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
weight
Délai: 84days
weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
BMI:Body Mass Index
Délai: 84days
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Body fat percent
Délai: 84days
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Waist
Délai: 84days
Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Obesity associated gut microbiome(Bacteriodetes)
Délai: 84days
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Obesity associated gut microbiome(Firmicutes)
Délai: 84days
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Hypoglycemic(oral medication)
Délai: 84days
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Control blood pressure(oral medication)
Délai: 84days
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Lipid modifying (oral medication)
Délai: 84days
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chonbuk National University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2010

Achèvement primaire (Réel)

1 janvier 2011

Achèvement de l'étude (Réel)

1 février 2011

Dates d'inscription aux études

Première soumission

29 octobre 2012

Première soumission répondant aux critères de contrôle qualité

9 novembre 2012

Première publication (Estimation)

12 novembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 novembre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2012

Dernière vérification

1 novembre 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CUH_KOREAN-FOOD_2-2_2010

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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