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Diabetes Mellitus, Type 2NCT01724645

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

A study testing Korean traditional diets in people with Diabetes Mellitus, Type 2, run by Chonbuk National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Korean traditional diets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
Sep 2010to Feb 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 560-822

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Korean traditional diets, Control group
Keywords
Korean Traditional diets, hypertension, diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Korean traditional dietsDietary supplement

    Also called The Korean Traditonal 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.

  • Control groupDietary supplement

    Also called Control diets

    Told to " eat as usal diets".

Study groups in NCT01724645
Study groupRoleWhat they receive
Korean traditional dietsExperimentalKorean traditional diets (calorie 2,100kcal) for 12weeks
Receives: Dietary Supplement: Korean traditional diets
Control groupActive comparatorControl group : told to "eat as usal diet) for 12weeks
Receives: Dietary Supplement: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1C :Glycated Hemoglobin

    Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

Secondary outcomes (18)

  1. TG :Triglycerides

    Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  2. TC :Total cholesterol

    Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  3. HDL-C :High Density Lipoprotein-Cholesterol

    HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  4. LDL-C : Low Density Lipoprotein-Cholesterol

    LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  5. Breathing score

    Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.

    Measured: 84days

  6. Valsalva score

    Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.

    Measured: 84days

  7. Upright score

    Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.

    Measured: 84days

  8. ApoA1 :Apolipoprotein A1

    Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  9. ApoB :Apolipoprotein B

    Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  10. Apo E :Apolipoprotein E

    Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  11. Free fatty acid

    Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  12. Adiponectin

    Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  13. PAI-1 :Plasminogen activator inhibitor type 1

    PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  14. Homocysteine

    Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  15. FPG :Fasting plasma glucose

    Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  16. DBP:Diastolic Blood Pressure

    DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  17. SBP:Systolic Blood Pressure

    SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

  18. Heart rate

    Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

    Measured: 84days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01724645
Sponsor's protocol ID
CUH_KOREAN-FOOD_2-2_2010
Status last verified
Nov 2012
First submitted
29 Oct 2012
Last updated
12 Nov 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Korean traditional diets in people with Diabetes Mellitus, Type 2, run by Chonbuk National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1C :Glycated Hemoglobin (time frame: 84days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01724645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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