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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020330
Receipt No. 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

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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
Email 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
Email ht240z@sa3.so-net.ne.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023484

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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