None listed
Conditions
Interventions
Drug, Behavioral : Assess 3 groups(Conventional Management group, Life style modification group, Metformin group) from the baseline for 36 months.
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 / dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of Dibetes Mellitus | — |
Secondary
| Measure | Time frame |
|---|---|
| Change on HbA1c and Fasting Blood Sugar;Change on HOMA2%S;Change on HOMA2%B | — |
Countries
Korea, Republic of
Contacts
Public ContactSuk Chon
Kyung Hee University Hospital
Outcome results
None listed