UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026825 |
|---|---|
| Receipt number | 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 20:16:22 |
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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
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
tspitt@med.niigata-u.ac.jp
Sponsor or person
Institute
Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030792
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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