UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044395 |
|---|---|
| Receipt number | 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 | 2021/11/30 11:46:06 |
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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
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
goshi@joetsu-hp.jp
Sponsor or person
Institute
Joetsu general hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044428
