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Hospital-based Diabetes Prevention Study in Korea

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Kyunghee University Medical Center
Sponsor:
Collaborators:
National Evidence-Based Healthcare Collaborating Agency
Kyungpook National University
Korea University Guro Hospital
Pusan National University Hospital
Samsung Medical Center
Seoul National University Hospital
Asan Medical Center
Ajou University School of Medicine
Severance Hospital
Chonbuk National University Hospital
Information provided by (Responsible Party):
Jeong-taek Woo, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT02981121
First received: November 28, 2016
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.

Condition Intervention Phase
PreDiabetes
Behavioral: Exercise and Diet remedies
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Cumulative incidence of Diabetes Mellitus after randomization [ Time Frame: 36 months from the baseline ] [ Designated as safety issue: No ]

    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%


Secondary Outcome Measures:
  • Change on HbA1c [ Time Frame: 12, 24, 36 months from the baseline ] [ Designated as safety issue: No ]
  • Change on Fasting Glucose [ Time Frame: 12, 24, 36 months from the baseline ] [ Designated as safety issue: No ]
  • Change on HOMA2%S [ Time Frame: 12, 24, 36 months from the baseline ] [ Designated as safety issue: No ]
  • Change on HOMA2%B [ Time Frame: 12, 24, 36 months from the baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 744
Study Start Date: November 2016
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional Management
A 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.
Experimental: Life style modification

Proceed 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.
Behavioral: Exercise and Diet remedies
Active Comparator: Metformin
After 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.
Drug: Metformin

  Eligibility

Ages Eligible for Study:   31 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 31≤Age<65
  2. BMI≥23 kg/m2
  3. 75g Oral glucose tolerance 2 hours after the test Blood glucose ≥ 200 mg / dL ' or 'Fasting Blood Sugar 100~125 mg/dL' or 'HbA1c 5.7%~6.4%'

Exclusion Criteria:

  1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
  2. 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
    • 75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
    • HbA1c ≥ 6.5%
  3. 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 +)
    • Anemia(Hematocrit <36%((male) or><33%(female)) ⑤ Cirrhosis or chronic active hepatitis (AST/ALT>3UNL)
    • Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)
    • Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.
    • Chronic infection (HIV, active tuberculosis, etc.)
    • Pulmonary patients who rely on oxygen or daily bronchodilators
  4. Who is judged to be able to influence the clinical trial by investigator.

    • Who can not communicate
    • Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
    • Those who do not agree to the treatment group allocation by random assignment
    • Those who participate in other studies that may interfere with the clinical trial
    • Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
    • Those who can not have normal walking or exercise
    • Women who are pregnant
    • Those who are currently pregnant or who are within the last 3 months after giving birth
    • Those planning pregnancy during the clinical trial period
    • Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
    • Those who are not appropriate or unreliable for clinical trials at the discretion of the tester
  5. Who taking medication or medical condition that may affect the diagnosis of diabetes

    • Thiazide diuretics
    • Systemic beta blockers
    • Taking Niacin for the treatment of neutropenic depression
    • Possibility of taking or injecting a systemic steroid preparation
    • Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
    • Taking medicine for weight loss
    • Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range) (If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
    • Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
    • During treatment, fasting plasma triglyceride> 600 mg / dL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02981121

Contacts
Contact: Jeong-Taek Woo 822-958-8220 jtwoomd@khmc.or.kr
Contact: Sang Youl Rhee 822-958-8220 bard95@hanmail.net

Locations
Korea, Republic of
Kyunghee University Medical Center Recruiting
Seoul, Korea, Republic of, 02447
Contact: Jeong-taek Woo, MD, PhD    +82-2-958-8128    jtwoomd@khmc.or.kr   
Contact: Sang Youl Rhee, MD, PhD    +82-2-958-8220    bard95@hanmail.net   
Principal Investigator: Jeong-taek Woo, MD, PhD         
Sub-Investigator: Suk Chon, MD, PhD         
Sub-Investigator: Sang Youl Rhee, MD, PhD         
Sponsors and Collaborators
Jeong-taek Woo
National Evidence-Based Healthcare Collaborating Agency
Kyungpook National University
Korea University Guro Hospital
Pusan National University Hospital
Samsung Medical Center
Seoul National University Hospital
Asan Medical Center
Ajou University School of Medicine
Severance Hospital
Chonbuk National University Hospital
  More Information

Responsible Party: Jeong-taek Woo, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02981121     History of Changes
Other Study ID Numbers: KDPS 
Study First Received: November 28, 2016
Last Updated: November 30, 2016
Health Authority: Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Kyunghee University Medical Center:
Diabetes Prevention

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016