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ClinicalTrials.gov Identifier: NCT00464594
Recruitment Status : Unknown
Verified April 2007 by Japan Early Diabetes Intervention Study Group. Recruitment status was: Recruiting
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).
Condition or disease
Behavioral: Standard lifestyle guidanceDrug: Lifestyle guidance and monotherapy with acarboseDrug: Lifestyle guidance and monotherapy with metforminDrug: Lifestyle guidance and monotherapy with gliclazide
In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.
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Layout table for eligibility information
Ages Eligible for Study:
30 Years to 69 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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%
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