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| Name | Class |
|---|---|
| National Evidence-Based Healthcare Collaborating Agency | OTHER_GOV |
| Kyungpook National University Hospital | OTHER |
| Korea University Guro Hospital | OTHER |
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The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Management | No Intervention | 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. | |
| Life style modification | Experimental | 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).
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| Metformin | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and Diet remedies | Behavioral |
| ||
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of Diabetes Mellitus after randomization | Definition of "incidence of Diabetes Mellitus"
| 36 months from the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
Type 2 Diabetes Mellitus
Who life expectancy is short.
Cardiac history
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
Who is judged to be able to influence the clinical trial by investigator.
Who taking medication or medical condition that may affect the diagnosis of diabetes
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong-Taek Woo | Contact | 822-958-8220 | jtwoomd@khmc.or.kr | |
| Sang Youl Rhee | Contact | 822-958-8220 | bard95@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyunghee University Medical Center | Recruiting | Seoul | 02447 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30398039 | Derived | 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. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Pusan National University Hospital |
| OTHER |
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Asan Medical Center | OTHER |
| Ajou University School of Medicine | OTHER |
| Severance Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
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| Drug |
|
| 12, 24, 36 months from the baseline |
| Change on HOMA2%B | 12, 24, 36 months from the baseline |
| D004700 | Endocrine System Diseases |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |