- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01724645
Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korean tasavalta, 560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
|
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.
Muut nimet:
|
Active Comparator: Control group
Control group : told to "eat as usal diet) for 12weeks
|
Told to " eat as usal diets".
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
HbA1C :Glycated Hemoglobin
Aikaikkuna: 84days
|
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
TG :Triglycerides
Aikaikkuna: 84days
|
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
TC :Total cholesterol
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 84days
|
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Breathing score
Aikaikkuna: 84days
|
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
Valsalva score
Aikaikkuna: 84days
|
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
Upright score
Aikaikkuna: 84days
|
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
|
84days
|
ApoA1 :Apolipoprotein A1
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 84days
|
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Adiponectin
Aikaikkuna: 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
Aikaikkuna: 84days
|
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Homocysteine
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 84days
|
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Heart rate
Aikaikkuna: 84days
|
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
weight
Aikaikkuna: 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
Aikaikkuna: 84days
|
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Body fat percent
Aikaikkuna: 84days
|
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Waist
Aikaikkuna: 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)
Aikaikkuna: 84days
|
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
Obesity associated gut microbiome(Firmicutes)
Aikaikkuna: 84days
|
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
Hypoglycemic(oral medication)
Aikaikkuna: 84days
|
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
Control blood pressure(oral medication)
Aikaikkuna: 84days
|
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
Lipid modifying (oral medication)
Aikaikkuna: 84days
|
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CUH_KOREAN-FOOD_2-2_2010
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