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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041542
Receipt No. R000047427
Scientific Title Development of blood glucose control index in enteral nutrition therapy for acute diseases
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/25

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Basic information
Public title Factors affecting blood glucose control during enteral nutrition therapy
Acronym Enteral nutrition and blood glucose control
Scientific Title Development of blood glucose control index in enteral nutrition therapy for acute diseases
Scientific Title:Acronym Blood glucose control index in enteral nutrition
Region
Japan

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

Objectives
Narrative objectives1 Increased therapeutic demand for glycemic control is often clinically experienced when compared to similar oral ingested calories during various enteral nutrition regimens. The purpose is to search for physiological factors that influence the change in the demand.
Basic objectives2 Others
Basic objectives -Others Among the various enteral nutrition methods, the factors that influence glycemic control will also be examined at the same time.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Confirm of blood GLP-1 concentration after tube feeding and oral intake of the same calorie
Key secondary outcomes 1)Effect of enteral nutrition regimen on blood glucose
2) Factors for insulin reduction or withdrawal after enteral nutrition

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among patients undergoing hospitalization for various acute illnesses, those who are eligible for enteral nutrition and who are expected to withdraw from tube feeding in the future.
Key exclusion criteria Those who have undergone surgical resection due to digestive disorders.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Watanabe
Organization Saku central hospital advanced care center
Division name Endocrinology and metabolism
Zip code 385-0051
Address Nakagomi, Saku-shi, Nagano 385-0051, Japan
TEL 0267-82-8181
Email takuyaw.yks@gmail.com

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Watanabe
Organization Saku central hospital advanced care center
Division name Endocrinology and metabolism
Zip code 385-0051
Address Nakagomi, Saku-shi, Nagano 385-0051, Japan
TEL 0267-82-8181
Homepage URL
Email takuyaw.yks@gmail.com

Sponsor
Institute Saku central hospital group
Clinical research and clinical trial review committee
Institute
Department

Funding Source
Organization Saku central hospital advanced care center
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 Saku Central Hospital Group Research Ethics Committee
Address 197 Usuda, Saku, 384-0301 JAPAN
Tel 0267-82-3131
Email ctroffice@sakuhp.or.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 08 Month 31 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 04 Day
Date of IRB
2019 Year 07 Month 04 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information When the target patient is hospitalized and if consent, blood is collected. Specimens are analyzed in the laboratory using the ELISA method.

Management information
Registered date
2020 Year 08 Month 25 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047427

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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