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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044395
Receipt No. R000044428
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-
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/01

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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 Open public recruiting
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 10 Month 01 Day
Date of closure to data entry
2021 Year 10 Month 31 Day
Date trial data considered complete
2021 Year 11 Month 30 Day
Date analysis concluded
2021 Year 12 Month 28 Day

Other
Other related information

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


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

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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