UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of single administration of palatinose on metabolisms in patients with non-alcoholic fatty liver disease
Title of the study (Brief title)	Effects of palatinose on metabolisms in patients with non-alcoholic fatty liver disease
Region	Japan

Condition
Condition	non-alcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate effects of palatinose on metabolisms in patients with non-alcoholic fatty liver disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in glucose and lipid metabolisms (glucose, insulin, free fatty acids, GLP-1, GIP-1, FGF-21) 180 min. after palatinose administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	palatinose/sucrose
Interventions/Control_2	sucrose/palatinose
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	Patients who can be treated by oral administration Patients who agreed this study with written informed consent
Key exclusion criteria	Diabetic patients with HbA1c > 8.0 Severe complication of diabetes mellitus Severe cardiovascular disease Severe liver disease Patients who can not be treated by oral administration Severe renal disease Risk of esophageal varix rupture Heart failure Diabetic patients treated with alpha-glucoseidase inhibitor
Target sample size	10

Research contact person
Name of lead principal investigator	Takumi Kawaguchi
Organization	Kurume University School of Medicine
Division name	Division of Gastroenteorlogy, Department of Medicine
Address	67 Asahi-machi, Kurume 830-0011, Japan.
TEL	0942-35-3311
Email	takumi@med.kurume-u.ac.jp

Public contact
Name of contact person	Takumi Kawaguchi
Organization	Kurume University School of Medicine
Division name	Division of Gastroenteorlogy, Department of Medicine
Address	67 Asahi-machi, Kurume 830-0011, Japan.
TEL	0942-35-3311
Homepage URL
Email	takumi@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	Mitsui Sugar Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 26 Day
Last follow-up date	2018 Year 12 Month 11 Day
Date of closure to data entry	2018 Year 12 Month 11 Day
Date trial data considered complete	2018 Year 12 Month 11 Day
Date analysis concluded	2018 Year 12 Month 11 Day

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

Management information
Registered date	2017 Year 01 Month 26 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029743