UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study of vitamin and amino acid deficiency in diabetic patients
Acronym	Cross-sectional study of vitamin and amino acid deficiency in diabetic patients
Scientific Title	Cross-sectional study of vitamin and amino acid deficiency in diabetic patients
Scientific Title:Acronym	Diabetes-V study
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify which vitamin or amino acid are deficient in diabetic patients with poor glycemic control
Basic objectives2	Others
Basic objectives -Others	To comprehensively search various serum vitamin and amino acid concentrations in diabetic patients with poor glycemic control.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvement of glycemic control
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	Not applicable
Gender	Male
Key inclusion criteria	Type 2 diabetes patients who admit to our hospital for improvement of poor diabetic control.
Key exclusion criteria	(1) Patients who have fasted for 3 days or more due to poor appetite at the time of enrollment, or are undergoing enteral or tube feeding (2) Pregnant and dialysis patients at the time of enrollment (3) Patients who are using over-the-counter supplements and vitamins within one month before enrollment
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Saito
Organization	Shizuoka Prefectural Hospital Organization
Division name	Department of Endocrinology and Diabetes
Zip code	420-8527
Address	4-27-1 Kita-ando, Aoi-ku, Shizuoka-City 420-9527, JAPAN
TEL	0542476111
Email	kohei-saito@i.shizuoka-pho.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Saito
Organization	Shizuoka Prefectural Hospital Organization
Division name	Department of Endocrinology and Diabetes
Zip code	420-8527
Address	4-27-1 Kita-ando, Aoi-ku, Shizuoka-City 420-9527, JAPAN
TEL	0542476111
Homepage URL
Email	kohei-saito@i.shizuoka-pho.jp

Sponsor
Institute	Shizuoka Prefectual Hospital Organization
Institute
Department

Funding Source
Organization	Shizuoka Prefectual Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shizuoka Prefectural Hospital Organization Research Support Office
Address	4-27-1 Kita-ando, Aoi-ku, Shizuoka-City 420-9527, JAPAN
Tel	0542476111
Email	chiken-sougou@shizuoka-pho.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	2020 Year 03 Month 27 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	Terminated
Date of protocol fixation	2019 Year 06 Month 07 Day
Date of IRB	2019 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 03 Month 09 Day
Last follow-up date	2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is Single Arm study. Our purpose is searching for clinically significant vitamin and amino acid for patients with diabetes by comprehensively measuring serum vitamin and serum amino acid.This study is a preliminary study for future translational clinical research.

Management information
Registered date	2020 Year 03 Month 27 Day
Last modified on	2021 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045477