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

UMIN ID: UMIN000001588

Registered date:25/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2009/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Complication by stage 3B or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease (CKD) not associated with diabetes. 2. Malignant or acute disease. 3. Severe liver disease. 4. Decreased pancreatic function due to chronic pancreatitis, etc. 5. Past history of surgery of the gastrointestinal tract or complication by gastrointestinal disease requiring dietary restriction. 6. Heart failure. 7. Pregnant or lactating women 8. Under insulin treatment 9. Under steroid treatment 10. Patient judged to have difficulty in performing dietetics on his/her own due to dementia, etc. 11. Other patients judged unsuitable by the attending physician.

Related Information

• Primary Sponsor: 4C-study Research Group
• Secondary Sponsor: None
• Source(s) of Monetary Support: None,None