UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001645
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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.
Acronym DIMS Improves glucose and lipids Metabolism in type 2 diabetes Study
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.
Scientific Title:Acronym DIMS Improves glucose and lipids Metabolism in type 2 diabetes Study
Region
Japan

Condition
Condition Type-2 diabetic patient who has been being hospitalized in our facilities is bedridden and takes liquid diet.
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Primary endpoints: Changes of fasting and postprandial 2-hr plasma glucose levels, HbA1c, fasting and postprandial 2- and 4-hr serum triglyceride levels.
Key secondary outcomes 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).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 The subjects were given DIMS orCZ1.5, and the evaluative parameters as above were measured before administration and 12 weeks later.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key 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.
Key exclusion 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Abe MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7163
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Ogawa MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7266
Homepage URL
Email ogawa-s@m.tains.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine,Tohoku University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 19 Day
Last modified on
2015 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.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


Contact us.