UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041542 |
|---|---|
| Receipt number | 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 | 2022/08/30 03:30:29 |
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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
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
takuyaw.yks@gmail.com
Sponsor or person
Institute
Saku central hospital group
Clinical research and clinical trial review committee
Institute
Department
Personal name
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
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
Suspended
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
| 2024 | 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
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
