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

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 - Carbohydrate Counting and Calorie Counting study of dietary management in type 2 diabetic patients without insulin therapy (4C study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001588

Enrollment

200

Registered

2008-12-25

Start date

2009-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

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 p

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Glycemic control status (HbA1c)	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactShinya Fukumoto

Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine

sfukumoto@med.osaka-cu.ac.jp06-6645-3806

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026