Japan Early Diabetes Intervention Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Standard lifestyle guidance
* Drug: Lifestyle guidance and monotherapy with acarbose
* Drug: Lifestyle guidance and monotherapy with metformin
* Drug: Lifestyle guidance and monotherapy with gliclazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Standard lifestyle guidance|nan|
|Drug: Lifestyle guidance and monotherapy with acarbose|nan|
|Drug: Lifestyle guidance and monotherapy with metformin|nan|
|Drug: Lifestyle guidance and monotherapy with gliclazide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG >= 140mg/dl and HbA1c >= 7.0% |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japan Early Diabetes Intervention Study