UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039963
Receipt number R000045477
Scientific Title Cross-sectional study of vitamin and amino acid deficiency in diabetic patients
Date of disclosure of the study information 2020/03/27
Last modified on 2021/02/18 08:24:31

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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 or person

Institute

Shizuoka Prefectual Hospital Organization

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name