UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025866 |
|---|---|
| Receipt number | R000029743 |
| Scientific Title | Effects of single administration of palatinose on metabolisms in patients with non-alcoholic fatty liver disease |
| Date of disclosure of the study information | 2017/01/26 |
| Last modified on | 2018/12/11 21:42:54 |
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Basic information
Public title
Effects of single administration of palatinose on metabolisms in patients with non-alcoholic fatty liver disease
Acronym
Effects of palatinose on metabolisms in patients with non-alcoholic fatty liver disease
Scientific Title
Effects of single administration of palatinose on metabolisms in patients with non-alcoholic fatty liver disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takumi Kawaguchi |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenteorlogy, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942-35-3311
takumi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takumi Kawaguchi |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenteorlogy, Department of Medicine
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942-35-3311
Homepage URL
takumi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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)
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 | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029743
