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

UMIN ID: UMIN000002179

Registered date:10/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 2009/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Body weight
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Graduate School of Medicine, Yokohama City University
• Source(s) of Monetary Support: No