Hospital-based Diabetes Prevention Study in Korea

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeong-taek Woo
• Collaborators: Ajou University School of Medicine; Asan Medical Center; Chonbuk National University Hospital; Korea University Guro Hospital; Kyungpook National University; Kyungpook National University Hospital; National Evidence-Based Healthcare Collaborating Agency; Pusan National University Hospital; Samsung Medical Center; Seoul National University Hospital; Severance Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. 302. BMI≥23 kg/m2

3. '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:

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