UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study)
Title of the study (Brief title)	Classification and treatment of NAFLD based on pancreatic exocrine function
Region	Japan

Condition
Condition	Before starting enrollment
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this clinical study is a clarification of clinical usefulness to define a subtype in nonalcoholic fatty liver diseases (NAFLD) based on pancreatic exocrine function. For non-obese NAFLD patients, pancreatic exocrine function and efficacy to supplement pancreatic digestive enzymes are evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ultrasound findings for fatty liver 24 weeks after the enrollment
Key secondary outcomes	Shear wave velocity of the liver evoked by acoustic radiation force impulse

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Evaluation and encouraging in terms of energy-balanced life style and oral administration of pancrelipase (600 mg a day for 24 weeks)
Interventions/Control_2	Evaluation and encouraging in terms of energy-balanced life style
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	1) Ultrasound reveals fatty liver as two or more following criteria are fulfilled. i. Liver/kidney contrast ii. Vascular blurring in the liver iii. Deep-attenuation of echo-beam in the liver 2) Shear wave elastography is 1.41 m/sec or faster. 3) A written informed consent is obtained from a patient him/her self.
Key exclusion criteria	1) HBV positive 2) HCV positive including a SVR12 case 3) Alcohol consumption more than 20g/day 4) An organic diseases of pancreas or a past History of chronic pancreatitis 5) Allergy against porcine proteins 6) Already taking pancrelipase 7) Taking a medication for diabetes mellitus or HbA1c is 8 or higher 8) Serum triglyceride concentration is 1000 mg/dl or higher 9) Other serious conditions judged to be inadequate by a responsible doctor
Target sample size	60

Research contact person
Name of lead principal investigator	Takeshi Suda
Organization	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name	Department of Gastroenterology and Hepatology
Address	4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan
TEL	81-25-777-3200
Email	tspitt@med.niigata-u.ac.jp

Public contact
Name of contact person	Takeshi Suda
Organization	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name	Department of Gastroenterology and Hepatology
Address	4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan
TEL	81-25-777-3200
Homepage URL
Email	tspitt@med.niigata-u.ac.jp

Sponsor
Institute	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Institute
Department

Funding Source
Organization	Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
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	2017 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 06 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 01 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030792