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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2009
INTERVENTION: 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. CONDITION: Type‐2 diabetic patient who has been being hospitalized in our facilities is bedridden and takes liquid diet. 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). INCLUSION CRITERIA: Including criteria This study subject is assumed to meet the following requirements with type‐2 diabetes hospitalized in our facilities. 1) Subject who has been hospitalized in our facilities is bedridden and takes liquid diet. 2) Neither the calorie of the liquid diet nor the content have been changed for three months or more. 3) It has already been diagnosed as the diabetic or fasting blood glucose level is 126mg/dl or more. 4) It is necessary that the age is 20 years old or more. Sex is not asked.
Epistemonikos ID: 8e0d94d35d1145eb0cbf1776dd73c937b78ae04c
First added on: Aug 22, 2024