UMIN-CTR Clinical Trial

Basic information
Public title	Effect of carbohydrate content of liquid diet with viscosity variable in stomach on diurnal variation of glucose level in diabetic patients-Crossover comparative study-
Acronym	Effect of liquid diet management on diurnal variation of glucose levels in diabetic patients
Scientific Title	Effect of carbohydrate content of liquid diet with viscosity variable in stomach on diurnal variation of glucose level in diabetic patients-Crossover comparative study-
Scientific Title:Acronym	Effect of liquid diet management on diurnal variation of glucose levels in diabetic patients
Region	Japan

Condition
Condition	Cases indicated for tube feeding
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intragastric variable-type concentrated liquid diet on diurnal variation of glucose levels in diabetic patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Items related to glucose (maximum value, minimum value, mean value, circadian variation)
Key secondary outcomes	Bowel movements (stool frequency, stool characteristics, diarrhea frequency) Gastrointestinal symptoms (abdominal fullness, vomiting, nausea) Nutritional indices (transthyretin, body weight)

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A diabetic patient with an indwelling glucose monitoring device is administered Hine E-Gel through a tube for 2 days. The dosage should be determined with reference to the basal energy expenditure calculated from the Harris-Benedict equation. Two sets are performed before and after gastrostomy.
Interventions/Control_2	A diabetic patient with an indwelling glucose monitoring device is administered Hine E-Gel LC through a tube for 2 days. The dosage should be determined with reference to the basal energy expenditure calculated from the Harris-Benedict equation. Two sets are performed before and after gastrostomy.
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 and Female
Key inclusion criteria	1) Patients admitted to the hospital for gastrostomy 2) Patients with difficulty in oral intake and receiving tube feeding management 3) Patients diagnosed with diabetes mellitus who are taking antidiabetic drugs and whose blood glucose levels are stable 4) Patients who have given written and verbal explanations fully regarding the participation in this study, and have obtained consent from their own will
Key exclusion criteria	1) Patients with food allergies or potential allergic reactions to the products used in this study 2) Patients with difficulty in participating in this study due to the combination of hepatic disorder, renal disorder, heart disease, etc 3) Patients who are pregnant, lactating, or potentially pregnant 4) Patients who are considered inappropriate for the study by the attending physician
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Goshi Middle name Last name Satoshi
Organization	Joetsu general hospital
Division name	gastrointestinal medicine
Zip code	943-8507
Address	616, Daidofukuda, Joetsu-shi, Niigata, Japan
TEL	025-524-3000
Email	goshi@joetsu-hp.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Goshi
Organization	Joetsu general hospital
Division name	gastrointestinal medicine
Zip code	943-8507
Address	616, Daidofukuda, Joetsu-shi, Niigata, Japan
TEL	025-524-3000
Homepage URL
Email	goshi@joetsu-hp.jp

Sponsor
Institute	Joetsu general hospital
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Joetsu general hospital
Address	616, Daidofukuda, Joetsu-shi, Niigata, Japan
Tel	025-524-3000
Email	goshi@joetsu-hp.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	2021 Year 06 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
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	2019 Year 11 Month 30 Day
Date of IRB	2019 Year 12 Month 05 Day
Anticipated trial start date	2020 Year 01 Month 06 Day
Last follow-up date	2021 Year 09 Month 15 Day
Date of closure to data entry	2021 Year 09 Month 30 Day
Date trial data considered complete	2021 Year 10 Month 10 Day
Date analysis concluded	2021 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 06 Month 01 Day
Last modified on	2021 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044428