Hospital-based Diabetes Prevention Study in Korea

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 744

Inclusion Criteria

1. 30<Age<65
2. BMI=23 kg/m2
3. '75g OGTT: 140~199 mg/dL' or 'Fasting Blood Sugar 110~125' 'HbA1c 5.7%~6.4%'

Exclusion Criteria

1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
2. Type 2 Dibetes 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
? 2 hours after 75g OGTT = 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)) ? 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 Niacinfor 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 / d

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of Dibetes Mellitus

Secondary Outcome Measures

Name	Time	Method
Change on HbA1c and Fasting Blood Sugar;Change on HOMA2%S;Change on HOMA2%B

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