UMIN-CTR Clinical Trial

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