Newly-diagnosed early diabetes
Conditions
Interventions
Standard lifestyle guidance
Standard lifestyle guidance and pharmacological intervention (monotherapy with acarbose)
Standard lifestyle guidance and pharmacological intervention (monotherapy with metf
Sponsors
Japan Early Diabetes Intervention Study (JEDIS) Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Results of 75-g oral glucose tolerance test (75 g OGTT) conducted after candidate selection or, if available, results of 75 g OGTT conducted within the past 3 months, will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL (isolated post-challenge hyperglycemia [IPH]) and HbA1c <= 6.9% - If these are confirmed, 75-g OGTT will be re-tested within 3 months and if the results again show an IPH pattern as well as HbA1c of <= 6.9%, the person will be confirmed to have a diagnosis of newly diagnosed early diabetes, and then could be enrolled in the study.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression/worsening to definite diabetes mellitus: Subjects are judged to have progressed to definite diabetes when FPG >= 140mg/dl and HbA1c >= 7.0% are confirmed more than one occasion by central Progression and Safety Assessment committee. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression to warning glycemic level: Progression to a glycemic level warning means that more aggressive intervention should be done, for subjects with FPG >= 126 and HbA1c >= 6.5% - Appearance of diabetic microangiopathy (retinopathy or nephropathy) - Appearance of macroangiopathy | — |
Countries
Japan
Outcome results
None listed