Status:
UNKNOWN
Japan Early Diabetes Intervention Study
Lead Sponsor:
Japan Early Diabetes Intervention Study Group
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
30-69 years
Phase:
NA
Brief 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 guida...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
2560 Patients enrolled
Trial Details
Trial ID
NCT00464594
Start Date
April 1 2007
Last Update
April 24 2007
Active Locations (1)
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1
Tokyo Medical and Dental University
Tokyo, Japan, 113-8519