UMIN-CTR Clinical Trial

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
Email	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
Email	yfujita9@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042570