UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034667 |
|---|---|
| Receipt number | R000038839 |
| Scientific Title | Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study- |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/04/12 18:40:04 |
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Basic information
Public title
Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study-
Acronym
Effect on liver by metabolic surgery
Scientific Title
Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study-
Scientific Title:Acronym
Effect on liver by metabolic surgery
Region
| Japan |
Condition
Condition
Patients with fatty liver and type 2 diabates
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on improvement of fatty liver between metabolic surgery and medication therapies in patients with fatty liver and type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of hepatic steatosis and fibrosis in the blood test and image examination
Key secondary outcomes
1) Body weight, BMI and waist circumference
2) Total weight loss rate and excess weight loss rate
3) Blood pressure
4) Fasting plasma glucose
5) Adiponectin and reptin
6) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc)
7) Visceral fat mass and subcutaneous fat mass (HDS-2000 DUALSCAN)
8) Visceral fat mass and subcutaneous fat mass (computed tomography)
9) Body composition (InBody)
10) Dual-energy X-ray absorptiometry
11) Hepatic hepatosis and fibrosis index (calculation from blood tests)
12) Insulin kinetics with 75gOGTT
13) Liver biopsy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1) Patients whose BMI is more than 35 kg/m2 in operative group and more than 30 kg/m2 in control group
2) Patients who are 20-year-old or older
3) Patients suspected NASH/NAFLD
4) Patients who are able to understand the study and willing to provide written informed consent
Key exclusion criteria
1) Patients who are deemed to be unsuitable by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University
Division name
Diabetes and endocrinology
Zip code
060-8648
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-1161
kyuyong-cho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Oe |
| Middle name | |
| Last name | Yuki |
Organization
Hokkaido University Graduate School
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School
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
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japna
Tel
011-706-7636
crjimu@hunp.hokudai.ac.jp
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
| 2018 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluated the change of hepatic steatosis and fibrosis in the blood test and image examination.
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038839
