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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026825
Receipt No. R000030792
Scientific Title Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study)
Date of disclosure of the study information 2017/06/01
Last modified on 2017/04/01

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Basic information
Public title Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study)
Acronym Classification and treatment of NAFLD based on pancreatic exocrine function
Scientific Title Impact of exocrine insufficiency of pancreas and supplementation of pancreatic digestive enzymes on nonalcoholic fatty liver disease (REMOTE study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Suda
Organization Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Takeshi Suda
Organization Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
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)

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
2017 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
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

Other
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

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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