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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000969
Receipt No. 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

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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
Institute Kobe University Hospital
Institute
Department

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
URL(English) https://upload.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


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