A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Japan Early Diabetes Intervention Study Group
- Enrollment
- 2560
- Locations
- 1
- Primary Endpoint
- FPG >= 140mg/dl and HbA1c >= 7.0%
- Last Updated
- 19 years ago
Overview
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 guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).
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 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
FPG >= 140mg/dl and HbA1c >= 7.0%