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
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000001588
- Lead Sponsor
- 4C-study Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic control status (HbA1c)
- Secondary Outcome Measures
Name Time Method 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)