UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001784 |
|---|---|
| Receipt number | R000002149 |
| Scientific Title | Study for necessity of insulin treatment in two enteral feeding formulas which are different in carbohydrates and fatty acids concentrations in tube-fed subjects with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2009/03/23 |
| Last modified on | 2010/09/22 10:48:21 |
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Basic information
Public title
Study for necessity of insulin treatment in two enteral feeding formulas which are different in carbohydrates and fatty acids concentrations in tube-fed subjects with type 2 diabetes mellitus
Acronym
Necessity of insulin treatment and enteral feeding formulas in type 2 diabetes
Scientific Title
Study for necessity of insulin treatment in two enteral feeding formulas which are different in carbohydrates and fatty acids concentrations in tube-fed subjects with type 2 diabetes mellitus
Scientific Title:Acronym
Necessity of insulin treatment and enteral feeding formulas in type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, Cerebral vascular disease
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study whether an enteral feeding formula with low carbohydrates and high monosaturated fatty acids can reduce the necessity of insulin treatment in type 2 diabetes or not
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Necessity of insulin treatment
Key secondary outcomes
frequency of insulin injection, dose of insulin, glycemic control
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
enteral feeding formula low in carbohydrates and high in monosaturated fatty acids
Interventions/Control_2
standard enteral formula
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
subjects with type 2 diabetes who require permanent enteral feeding because of cerebral vascular disease
Key exclusion criteria
who cannot tolerate enteral tube feeding
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shu Meguro |
Organization
Saiseikai Central Hospital
Division name
internal medicine
Zip code
Address
1-4-17, Mita, Minato-ku, Tokyo
TEL
03-3451-8211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Meguro |
Organization
Saiseikai Central Hospital
Division name
internal medicine
Zip code
Address
1-4-17, Mita, Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Saiseikai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2009 | Year | 03 | Month | 23 | 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
The study had terminated because the sufficient number of patients had not participated this study.
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
Terminated
Date of protocol fixation
| 2009 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 18 | Day |
Last modified on
| 2010 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002149
