An open label multi facilities cooperation randomized control trial to verify postprandial hyperglycemia and hypertriglyceridemia improving effects of DIMS therapy in type 2 diabetes. reducing effect of olmesartan therapy in diabetic nephropathy.

UMIN ID: UMIN000001645

Registered date:01/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type-2 diabetic patient who has been being hospitalized in our facilities is bedridden and takes liquid diet.
• Date of first enrollment: 2009/01/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

This Study is a prospective randomized control trial. The entry period of this study is one year. Subjects are type-2 diabetes, who has taken liquid diets. The subjects are randomly assigned to two groups, a DIMS group and CZ1.5 group. In the one that each liquid diet has already been marketed, these nutritional contents are almost the same excluding EPA, DHA, and diet fiber. DIMS far contains a lot of EPA and DHA and diet fiber from CZ1.5.
The subjects were given DIMS orCZ1.5, and the evaluative parameters as above were measured before administration and 12 weeks later.

Outcome(s)

• Primary Outcome: Primary endpoints: Changes of fasting and postprandial 2-hr plasma glucose levels, HbA1c, fasting and postprandial 2- and 4-hr serum triglyceride levels.
• Secondary Outcome: Secondary endpoints: Changes of urinary C-peptide excretion (CPR), fatty acids (FA), HDL-cholesterol (HDL-C), total cholesterol (TC), remnant like particle (RLP)-TG, apolipoprotein B, apolipoprotein AI, adiponectine, tumor necrosis factor (TNF) alpha, plasma monocyte chemoattractant protein (MCP)-1, interleukin (IL)-6, urinary 8-epi prostaglandin F2alpha (8-epi) 8-hydroxydeoxyguanosine(8-OHdG), albumin excretion (albumin to creatinine ratio: ACR), blood pressure (BP) and body weight (BW).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Excluding criteria 1) Patient who suffers from serious diseases. 2) Patient who suffers from malignant diseases. 3) Subjects of having received dialysis. 4) Patient who has already taken low carbohydrate liquid diet. 5) Patient that there is allergy in element of liquid diet.

Related Information

• Primary Sponsor: Graduate School of Medicine,Tohoku University
• Source(s) of Monetary Support: None