UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000969
Receipt number R000001164
Scientific Title Effects of fenofibrate or eiocosapentaenoic acid(EPA) on glucose metabolism, fat distribution, adipocytokines and inflammatory cytokines in type 2 Diabetes.
Date of disclosure of the study information 2008/01/07
Last modified on 2010/05/30 23:00:09

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Basic information

Public title

Effects of fenofibrate or eiocosapentaenoic acid(EPA) on glucose metabolism, fat distribution, adipocytokines and inflammatory cytokines in type 2 Diabetes.

Acronym

FiEPA study

Scientific Title

Effects of fenofibrate or eiocosapentaenoic acid(EPA) on glucose metabolism, fat distribution, adipocytokines and inflammatory cytokines in type 2 Diabetes.

Scientific Title:Acronym

FiEPA study

Region

Japan


Condition

Condition

type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study whether antihyperlipidemic drug to treat hypertriglyceridemia and/or hypo HDL cholesterolemia(fenofibrate or EPA) affect glucose metabolism, insulin resistance, fat distribution, and some adipocytokines or inflammatory cytokines.(interventional study)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

1. Evaluation of the effects on glucose metabolism and insulin sensitivity calculated with oral glucose tolerance test before and after 12 weeks treatment.
2. Measurement of the amount visceral fat, intramyocellular lipid content(IMCL) and hepatic lipid content(HLC) before and after 12 weeks treatment.

Key secondary outcomes

3. Measurement of HbA1c, total-cholesterol, LDL-cholesterol, triglyceride, FFA, oxidized LDL, Lipoprotein(a), remnant-like particle lipoorotein(RLP), adipocytokines, inflammatory cytokines, oxidative stress marker before and after 12 weeks treatment.
4. Measurement of body weight and waist before and after 12 weeks treatment.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

fenofibrate (100-200mg/day)

Interventions/Control_2

eicosapentaenoic acid(EPA) (1800mg/day)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

type 2 diabetes mellitus Japanese patients not administered with thiazolidinediones.

Key exclusion criteria

1. Severe hypercholesterolemia(LDL>140mg/dl)
2. Severe deficiency of insulin secretion
3. Severe renal dysfunction (serum creatinin>2.0mg/dl)
4. Severe liver dysfunction (AST, ALT>50IU/ml)
5. Severe herat failure
6. History of hypersensitivity to pioglitazone or metformin.
7. During the pregnancy and nursing
8. Inadequately BS contrilled (FBG>150mg/dl)
9. Inadequate to entry this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017

TEL

078-382-5861

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017

TEL

078-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kobe University Graduate School of Medicine
Department of radiology

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

2008 Year 01 Month 07 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

Terminated

Date of protocol fixation

2007 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 01 Month 06 Day

Last modified on

2010 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001164


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name