Japan Early Diabetes Intervention Study

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Early Diabetes Intervention Study Group
• Treatments: Acarbose; Gliclazide; Metformin

Criteria

Inclusion Criteria:

• Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9%

Exclusion Criteria:

• Type 1 diabetes mellitus

• Undergoing treatment with steroids

• Secondary diabetes mellitus

• Diabetes mellitus due to suspected gene abnormalities

• BMI >= 35 kg/m2 or BMI < 18.5 kg/m2

• Undergone a surgery

• Severe hyperuricemia (gout) associated with organ dysfunction

• Severe vascular diseases with organ dysfunction

• Cancer or other malignant neoplasms

• Liver cirrhosis or chronic hepatic, chronic renal failure

• Gastrointestinal disorders

• Always performing rigorous muscular exercise

• Severe infection or serious trauma

• Women who are pregnant

• Alcohol dependence or drug dependence

• Drug allergy

• Anemic

• Abnormal hemoglobinuria

• Severe mental disease