UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026950 |
|---|---|
| Receipt number | R000030911 |
| Scientific Title | The effect of glycemic control with basal-bolus insulin therapy under short term hospitalization on chylomicron metabolism |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2017/04/11 17:16:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of glycemic control with basal-bolus insulin therapy under short term hospitalization on chylomicron metabolism
Acronym
The effect of basal-bolus insulin therapy on chylomicron metabolism
Scientific Title
The effect of glycemic control with basal-bolus insulin therapy under short term hospitalization on chylomicron metabolism
Scientific Title:Acronym
The effect of basal-bolus insulin therapy on chylomicron metabolism
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of basal-bolus insulin therapy on chylomicron metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of the daily profile of serum lipids and the particle size of chylomicron between before and after glycemic control.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
basal bolus insulin therapy
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who agree to hospitalization for diabetic control
Key exclusion criteria
Treated with insulin
have a history or evidence of
severe liver disease
severe renal disease
endocrine disease
carcinoma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumitaka Okajima |
Organization
Nippon Medical School Chiba-Hokusoh Hospital
Division name
Division of Endocrinology, Department of Medicine
Zip code
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-476-99-1111
okaji@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumitaka Okajima |
Organization
Nippon Medical School, Chiba-Hokusoh Hospital
Division name
Division of Endocrinology, Department of Medicine
Zip code
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-99-1111
Homepage URL
okaji@nms.ac.jp
Sponsor or person
Institute
Division of Endocrinology, Department of Medicine, Chiba-Hokusoh Hospital, Nippon Medical School,
Institute
Department
Personal name
Funding Source
Organization
Japan Society for The Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
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
| 2017 | Year | 04 | Month | 11 | 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
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2017 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030911
