Hospital-based Diabetes Prevention Study in Korea
1 other identifier
interventional
744
1 country
1
Brief Summary
The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJuly 25, 2017
July 1, 2017
3 years
November 28, 2016
July 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative incidence of Diabetes Mellitus after randomization
Definition of "incidence of Diabetes Mellitus" * Fasting Glucose ≥126 mg/dL or * 75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or * HbA1c≥6.5%
36 months from the baseline
Secondary Outcomes (4)
Change on HbA1c
12, 24, 36 months from the baseline
Change on Fasting Glucose
12, 24, 36 months from the baseline
Change on HOMA2%S
12, 24, 36 months from the baseline
Change on HOMA2%B
12, 24, 36 months from the baseline
Study Arms (3)
Conventional Management
NO INTERVENTIONA patient will receive 30 minutes of individual education from the investigator, based on the standard guidelines of the Korean Diabetes Association. And will be followed up every 6 months for 36 months.
Life style modification
EXPERIMENTALProceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit). * Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day) * Diet remedies: Train Calorie intake, nutrient intake and Monitoring.
Metformin
ACTIVE COMPARATORAfter randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.
Interventions
Eligibility Criteria
You may qualify if:
- \<Age\<71
- BMI≥23 kg/m2
- '75g Oral glucose tolerance 2 hours after the test Blood glucose140\~199mg/dL' or 'Fasting Blood Sugar 110\~125 mg/dL' or 'HbA1c 5.7%\~6.4%'
You may not qualify if:
- Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
- Type 2 Diabetes Mellitus
- Who diagnosed with Diabetes Mellitus except for maternity period.
- Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
- Fasting Glucose≥ 126 mg/dL
- g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
- HbA1c ≥ 6.5%
- Who life expectancy is short.
- Cardiac history
- History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
- Systolic blood pressure \>180 mmHg or Diastolic blood pressure \>105 mmHg
- aortic stenosis
- Left bundle branch block or Third degree AV block
- Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years
- Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or Urine Protein ≥ 2 +)
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeong-taek Woolead
- National Evidence-Based Healthcare Collaborating Agencycollaborator
- Kyungpook National University Hospitalcollaborator
- Korea University Guro Hospitalcollaborator
- Pusan National University Hospitalcollaborator
- Samsung Medical Centercollaborator
- Seoul National University Hospitalcollaborator
- Asan Medical Centercollaborator
- Ajou University School of Medicinecollaborator
- Severance Hospitalcollaborator
- Chonbuk National University Hospitalcollaborator
Study Sites (1)
Kyunghee University Medical Center
Seoul, 02447, South Korea
Related Publications (1)
Rhee SY, Chon S, Ahn KJ, Woo JT; Korean Diabetes Prevention Study Investigators. Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study. Diabetes Metab J. 2019 Feb;43(1):49-58. doi: 10.4093/dmj.2018.0033. Epub 2018 Nov 2.
PMID: 30398039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 2, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2020
Last Updated
July 25, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share