UMIN-CTR Clinical Trial

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

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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 or person

Institute

Graduate School of Medicine,Tohoku University

Institute

Department

Personal name



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

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