UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037974 |
|---|---|
| Receipt number | R000042570 |
| Scientific Title | Assessment of biomarkers of macronutrient intake by food frequency questionnaire in healthy volunteers and patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/09/16 |
| Last modified on | 2020/03/30 09:25:24 |
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Basic information
Public title
Assessment of biomarkers of macronutrient intake by food frequency questionnaire in healthy volunteers and patients with type 2 diabetes
Acronym
Assessment of biomarkers of macronutrient intake
Scientific Title
Assessment of biomarkers of macronutrient intake by food frequency questionnaire in healthy volunteers and patients with type 2 diabetes
Scientific Title:Acronym
Assessment of biomarkers of macronutrient intake
Region
| Japan |
Condition
Condition
healthy volunteer, type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of biomarkers of macronutrient intake
Basic objectives2
Others
Basic objectives -Others
validation of biomarkers using food frequency questionnaire and human metabolome data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
metabolites
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy volunteer, type 2 diabetes
Key exclusion criteria
type 2 diabetes: mental disease, liver disease, renal impairment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
6068507
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513560
yfujita9@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
6068507
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513560
Homepage URL
yfujita9@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Medicine, Tokyo University
Kansai Electric Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine Kyoto university hospital Ethics committe
Address
yosida konoe, sakyo, kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 16 | 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
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042570
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
