Comparative study on the degree of caloric restriction of diet as a dietary treatment for obese patients with type 2 diabetes: a multi-center prospective, randomized, comparative study

Comparative study on the degree of caloric restriction of diet as a dietary treatment for obese patients with type 2 diabetes: a multi-center prospective, randomized, comparative study - 25 or 30 Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002179

Enrollment

100

Registered

2009-07-10

Start date

2009-06-01

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

25 kcal/IBW/day group: A nationally registered dietitian guides a calorie-restricted diet of 25 kcal/IBW/day. Periodic instruction is repeated during the 1-year study period. 30 kcal/IBW/day group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with type 2 diabetes mellitus. 2.BMI 25 or more. 3.Age, 20 to 80. 4.Patients after obtaining written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Patients who have a severe hepatic or renal dysfunction. 3.Patients who are on a low protein diet. 4.Patients who are in DKA state. 5.Patients who are 3 kg weight loss within 3 months. 6.Patients whom doctors in charge judge as inappropriate for the inclusion.

Design outcomes

Primary

Measure	Time frame
Body weight	—

Secondary

Measure	Time frame
1. Glycemic control status (HbA1c, FPG) 2. Lipid profile (LDL-C, HDL-C, TG) 3. Liver function (AST,ALT,r-GTP) 4. Continuation and performance of dietary treatment (energy intake) 5. Satisfaction and psychological complaints (questionnaire survey)	—

Countries

Japan

Contacts

Public ContactKiyomi Masuda

Graduate School of Medicine, Yokohama City University Department of Endocrinology and Metabolism

Outcome results

None listed

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