A Randomized Comparative Clinical Study on Suppression of Progression from Early Diabetes, Diet/exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention - Japan Early Diabetes Intervention Study (JEDIS)

Japan Early Diabetes Intervention Study (JEDIS) Group0 sites2,560 target enrollmentApril 18, 2007

Overview

No summary available.

Registry

who.int

Start Date

April 18, 2007

End Date

December 1, 2010

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Japan Early Diabetes Intervention Study (JEDIS) Group

•a. Type 1 diabetes mellitus b. Undergoing treatment with steroids c. Secondary diabetes mellitus d. Diabetes mellitus due to suspected mitochondrial gene abnormalities or other gene abnormalities e. Very obese (BMI \>\= 35 kg/m2\) or underweight (BMI \< 18\.5 kg/m2\) f. Undergone a gastrectomy or abdominal surgery g. Severe hyperuricemia (gout) associated with organ dysfunction caused by hyperuricemia h. Severe vascular diseases with organ dysfunction i. Cancer or other malignant neoplasms j. Liver cirrhosis or chronic hepatic, chronic renal failure k. Gastrointestinal disorders such as diarrhea and vomiting l. Always performing rigorous muscular exercise m. Severe infection or serious trauma or, who are scheduled to undergo or who have just undergone surgery n. Women who are pregnant or with a possibility of pregnancy o. Alcohol dependence or drug dependence p. Drug allergy q. Anemic (males: Hb \< 13 g/dL; females: Hb \< 11 /dL) r. Abnormal hemoglobinuria. s. Severe mental disease undergoing treatment, Other individuals whom the investigator deems unsuitable for inclusion in this study (e.g., individuals who are very likely to be transferred to another locality during the course of the study)