UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020330 |
|---|---|
| Receipt number | R000023484 |
| Scientific Title | Oral fat tolerance test for sitosterolemia and familial hypercholesterolemia |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2020/02/13 10:58:33 |
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Basic information
Public title
Oral fat tolerance test for sitosterolemia and familial hypercholesterolemia
Acronym
OFTT for sitosterolemia and familial hypercholesterolemia
Scientific Title
Oral fat tolerance test for sitosterolemia and familial hypercholesterolemia
Scientific Title:Acronym
OFTT for sitosterolemia and familial hypercholesterolemia
Region
| Japan |
Condition
Condition
Sitosterolemia
Familial Hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the metabolic basis of sitosterolemia at post-prandial state
Basic objectives2
Others
Basic objectives -Others
To investigate the remnant lipoprotein fractions at post-prandial state
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
RLP cholesterol(Before, 2hr, 4hr, 6hr)
Key secondary outcomes
Total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, RLP triglyceride, sitosterol, lathosterol, campesterol, APOA-1, APOA-2, APOB, APOC-2, APOC-3, APOE
(Before, 2hr, 4hr, 6hr)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
OFTT cream
(50g/body surface area square meter, orally only once)
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 6yr or greater
Patient who can provide written informed consent
Outpatient at Kanazawa University Hospital
Key exclusion criteria
Anemia
Lactose intolerance
Allergy for the content(s) of OFTT cream
Immunosuppressive therapy
Myocardial infarction or unstable angina
Liver dysfunction (AST or ALT 100 IU/L or greater)
Renal dysfunction(BUN 25 mg/dL or greater, or Cr 2.0 mg/dL or greater)
Female with pregnancy or expected
Patient whose doctor in charge consider it inappropriate to participate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tada |
| Middle name | |
| Last name | hayato |
Organization
Kanazawa University Hospital
Division name
Department of emergency medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa City, Ishikawa Prefecture, Japan
TEL
076-265-2000
ht240z@sa3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Tada |
Organization
Kanazawa University Hospital
Division name
Department of emergency medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa City, Ishikawa Prefecture, Japan
TEL
076-265-2000
Homepage URL
ht240z@sa3.so-net.ne.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
IRB of the Kanazawa University
Address
13-1 Takara-machi
Tel
0762652251
rinri@adm.kanazawa-u.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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29353827
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29998912
Number of participants that the trial has enrolled
15
Results
Significant elevation in RLP lipoproteins were observed in patienst with sitosterolemia.
Results date posted
| 2020 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
sitosterolemia cause by ABCG5 or ABCG8 gene mutations.
Participant flow
outpatient clinic
Adverse events
none
Outcome measures
Lipoprotein fractions after oral fat load.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023484
| 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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