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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037496
Receipt No. R000042727
Scientific Title Study on glycemic control in cases of jejunal nutrition
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/25

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Basic information
Public title Study on glycemic control in cases of jejunal nutrition
Acronym Study on glycemic control in cases of jejunal nutrition
Scientific Title Study on glycemic control in cases of jejunal nutrition
Scientific Title:Acronym Study on glycemic control in cases of jejunal nutrition
Region
Japan

Condition
Condition Patients undergoing enteral nutrition from the jejunum
Classification by specialty
Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the usefulness of low-carbohydrate nutrient formula for glycemic control in jejunal nutrition patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mean blood glucose levels
Standard deviation glucose values
Mean amplitude of glycemic excursions
Periods of hyperglycemia (>=140 mg/dL)
Periods of hypoglycemia (<70 mg/dL)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 standard formula (2 days administration) - low-carbohydrate formula (2 days administration)
Interventions/Control_2 low-carbohydrate formula (2 days administration) - standard formula (2 days administration)
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 1. The subjects are the patients who have been fed only with enteral nutrients through a jejunostomy tube for more than 3 weeks.
2. Patients who received sufficient explanation for participating in this study and who obtained written consent by the free will of the person or their family members.
Key exclusion criteria Patients who had
(1) received the combination of oral intake and parenteral nutrition
(2) acute infectious disease or administration of antibiotics within one week of enrollment
(3) a HbA1c level greater than 6.3%
(4) administration of diabetic medicine
(5) refusal to participate in this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Nishiwaki
Organization Nishimino Kosei Hospital
Division name Department of Internal Medicine
Zip code 503-1394
Address 986 Oshikoshi, Yoro-cho, Yoro-gun, Gifu 503-1394
TEL 0584-32-1161
Email pegwaki@yahoo.co.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Furuta
Organization Nishimino Kosei Hospital
Division name General Affairs Division
Zip code 503-1394
Address 986 Oshikoshi, Yoro-cho, Yoro-gun, Gifu 503-1394
TEL 0584-32-1161
Homepage URL
Email jicyo@nishimino.gfkosei.or.jp

Sponsor
Institute Nishimino Kosei Hospital
Institute
Department

Funding Source
Organization Nishimino Kosei Hospital
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 Institutional Review Board
Address 986 Oshikoshi, Yoro-cho, Yoro-gun, Gifu 503-1394
Tel 0584-32-1161
Email jicyo@nishimino.gfkosei.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 西美濃厚生病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 10
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 Completed
Date of protocol fixation
2015 Year 01 Month 13 Day
Date of IRB
2015 Year 02 Month 19 Day
Anticipated trial start date
2015 Year 09 Month 18 Day
Last follow-up date
2018 Year 11 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042727

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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