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

9. november 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republikken, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Kosttilskud: 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.

Andre navne:
  • The Korean Traditonal diets
Aktiv komparator: Control group
Control group : told to "eat as usal diet) for 12weeks
Kosttilskud: Control group
Told to " eat as usal diets".
Andre navne:
  • Control diets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1C :Glycated Hemoglobin
Tidsramme: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TG :Triglycerides
Tidsramme: 84days
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
TC :Total cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 84days
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Breathing score
Tidsramme: 84days
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Valsalva score
Tidsramme: 84days
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Upright score
Tidsramme: 84days
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
84days
ApoA1 :Apolipoprotein A1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 84days
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Adiponectin
Tidsramme: 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
Tidsramme: 84days
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Homocysteine
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 84days
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Heart rate
Tidsramme: 84days
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
weight
Tidsramme: 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
Tidsramme: 84days
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Body fat percent
Tidsramme: 84days
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Waist
Tidsramme: 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)
Tidsramme: 84days
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Obesity associated gut microbiome(Firmicutes)
Tidsramme: 84days
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Hypoglycemic(oral medication)
Tidsramme: 84days
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Control blood pressure(oral medication)
Tidsramme: 84days
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Lipid modifying (oral medication)
Tidsramme: 84days
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chonbuk National University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

29. oktober 2012

Først indsendt, der opfyldte QC-kriterier

9. november 2012

Først opslået (Skøn)

12. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CUH_KOREAN-FOOD_2-2_2010

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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