UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Title of the study (Brief title)	Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of sitagliptin on ectopic fat accumulation and glucose metabolism in type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intrahepatic lipid, intramyocellular lipid Glucose metabolism after oral glucose load HbA1c
Key secondary outcomes	Liver function test Body weight Body fat Visceral fat, subcutaneous fat volume

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	50 - 100mg of sitagliptine for 12 weeks
Interventions/Control_2
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	1. The type 2 diabetic patients whose HbA1c are between 6.5 % and 8.0%. 2. The patients with fatty liver. 3. The patients who have already started diet and exercise therapy for more than 6 months. 4. The patients who are more than 20 year-old. 5. Male or Female 6. The patients who are able to read and understand the written informed consent.
Key exclusion criteria	1) Type 1 diabetes 2) Heavy alcohol drinker 3) Patients who have serious liver disease 4) Patients who have serious kidney disease 5) Patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months) 6) Patients who have serious pancreatic disease 7) Patients with cancer 8) Patients who have viral infection (HBV,HCV) 9) Patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy 10) Patietns with serious infection, inflammation, or injuary. pre- or post- operative state 11) Patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus 12) Patients who are pregnant, hope to be pregnant, or are in lactation period 13) Patients who take pioglitazone 14) Patients who are not applicable to this study judged by the medical doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshifumi Tamura
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolisma and Endocrinology
Address	2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Email

Public contact
Name of contact person
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Address
TEL	03-5802-1579
Homepage URL
Email

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Research Conference on Japanese Diabetes Mellitus
Organization
Division
Category of Funding Organization	Non profit foundation
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	2011 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 11 Day
Anticipated trial start date	2011 Year 05 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 05 Month 30 Day
Last modified on	2017 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006677