Hospital-based Diabetes Prevention Study in Korea

Study Overview
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Brief Summary
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The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.

Official Title
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Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Exercise and Diet remedies
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30<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%' Exclusion Criteria: 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 75g 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 +) 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 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 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

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Management<br>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<br>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<br> <br> |
| Active Comparator: Metformin<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | 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 |  | 12, 24, 36 months from the baseline | 
| Change on HOMA2%B |  | 12, 24, 36 months from the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention