Unique ID issued by UMIN | UMIN000001645 |
---|---|
Receipt number | R000001966 |
Scientific Title | 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. |
Date of disclosure of the study information | 2009/03/01 |
Last modified on | 2015/06/08 10:14:15 |
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.
DIMS Improves glucose and lipids Metabolism in type 2 diabetes Study
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.
DIMS Improves glucose and lipids Metabolism in type 2 diabetes Study
Japan |
Type-2 diabetic patient who has been being hospitalized in our facilities is bedridden and takes liquid diet.
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
To clarify the follow hypothesis.: Administration of a DIMS, which is a liquid diet to which eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and diet fiber are increased, ameliorates not only fasting but also postprandial glucose-lipids metabolism and reduces oxidative stress and inflammation in type 2 diabetes.
Safety,Efficacy
Confirmatory
Pragmatic
Primary endpoints: Changes of fasting and postprandial 2-hr plasma glucose levels, HbA1c, fasting and postprandial 2- and 4-hr serum triglyceride levels.
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).
Interventional
Parallel
Randomized
Cluster
Open -but assessor(s) are blinded
Active
YES
NO
YES
No need to know
2
Treatment
Medicine |
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.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Takaaki Abe MD,PhD |
Tohoku University Hospital
Division of Nephrology, Endocrinology and Hypertension
1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
022-717-7163
1st name | |
Middle name | |
Last name | Susumu Ogawa MD,PhD |
Tohoku University Hospital
Division of Nephrology, Endocrinology and Hypertension
1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
022-717-7266
ogawa-s@m.tains.tohoku.ac.jp
Graduate School of Medicine,Tohoku University
None
Self funding
NO
2009 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 01 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2009 | Year | 01 | Month | 19 | Day |
2015 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001966
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |