UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of eicosapentaenoic acid on insulin sensitivity in patients with type2 diabetes mellitus and dyslipidemia: a randomized cross-over clinical trial.
Title of the study (Brief title)	The effect of EPA on insulin sensitivity
Region	Japan

Condition
Condition	Type2 diabetes and dyslipidemia
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and sefety of EPA in insulin sensitivity.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in hepatokine
Key secondary outcomes	1. Change in insulin sensitivity assessed by the glucose clamp technique 2. Blood glucose control (FPG, IRI, HbA1c) 3. Change in lipid metabolism (TC, HDL-C, TG, EPA/AA ratio) 4. Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference 5. Change in biochemical finding 6. Adverse events 7. Change in fecal metabolome

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral EPA administration for 3 months then ceasing EPA for 3 months
Interventions/Control_2	follow up for 3 months then starting oral EPA administration
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Type2 diabetes with dyslipidemia (TG>= 150 mg/dL) within 8 weeks before entry
Key exclusion criteria	1. Patients who have history of serious hypersensitivity to EPA. 2. Patients with diabetic ketoacidosis. 3. Patients who have history of severe hypoglycemia with coma or loss of consciousness. 4. Patients with serious infection or severe traumatic injury. 5. Patients who had EPA medication within 8 weeks before entry. 6. Patients with poor glysemic control and identified inappropriate for this study by the physicians in charge. 7. Patients with peritonial dialysis or hemodialysis or severe renal failure like CCR < 30ml/min, sCR <2.5mg/dL for male, or <2.0mg/dL for female. 8. Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg. 9. Patients with severe heart failure like NYHA III or IV, unstable angina, history of myocardial infarction within 1 year. 10. Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention 11. Patients who have history of malignancy, except for patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ or malignancy more than 1 year before and also have no reappearance. 12. Patients with severe complication and identified inappropriate patients for this study by the physicians in charge. 13. The pregnant women or women having possibilities of being pregnant and the women with breast-feeding. 14. Other patients who are identified inappropriate patients for this study by the physicians in charge.
Target sample size	20

Research contact person
Name of lead principal investigator	Toshinari Takamura
Organization	Kanazawa university
Division name	Department of Disease Control and Homeostasis
Address	13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
TEL	076-265-2234
Email	ttakamura@m-kanazawa.jp

Public contact
Name of contact person	Toshinari Takamura
Organization	Kanazawa university
Division name	Department of Disease Control and Homeostasis
Address	13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
TEL	076-265-2234
Homepage URL
Email	ttakamura@m-kanazawa.jp

Sponsor
Institute	Kanazawa university Department of Disease Control and Homeostasis
Institute
Department

Funding Source
Organization	Kanazawa university Department of Disease Control and Homeostasis
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2014 Year 11 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 05 Day
Anticipated trial start date	2014 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 12 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018139