An open-label, multicenter, randomized, controlled, parallel-group comparative study on the effectiveness of carbohydrate-counting and calorie-counting as a dietary management in type 2 diabetic patients treated without insulin therapy

INTERVENTION: Calorie���counting group: A nationally registered dietitian guides a calorie‐restricted diet of 25‐30 kcal/IBW/day using a food exchange list. Periodic guidance is repeated during the 6‐month study period. Manuals for each dietary intervention are provided and methods of guidance are shared among facilities. Carbohydrate‐counting group: A nationally registered dietitian guides a diet using criteria according to which carbohydrate amount is correspond to 50‐60% of a 25‐30 kcal/IBW/day diet. Periodic guidance is repeated during the 6‐month study period. Manuals for each dietary intervention are provided and methods of guidance are shared among facilities. CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Glycemic control status (HbA1c) SECONDARY OUTCOME: 1. Other measures of glycemic status (FPG, 1,5‐AG, IRI, rate of achievement of glycemic goal (HbA1c < 7.0 or < 6.5%)); 2. Body weight, BMI; 3. Lipid profile (LDL, HDL, TG, FFA, etc.); 4. Albuminuria; 5. Level of continuation and performance of dietary management (intake energy and nutrition survey); 6. Level of satisfaction with therapy, QOL (questionnaire survey) INCLUSION CRITERIA: 1. Patients with type 2 diabetes mellitus. 2. Age 20 to less than 70 years. 3. Under treatment with no antidiabetic agents, or with oral hypoglycemic drugs. 4. Not undergoing dietary intervention during the 6‐month period prior to initiation of the study. 5. Patients with HbA1c of 6.5‐10.0% at entry. 6. No initiation or changes in hypoglycemic drugs or antidyslipidemic drugs within the 3‐month period preceding initiation of the study.