UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024266 |
|---|---|
| Receipt number | R000027941 |
| Scientific Title | Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes. |
| Date of disclosure of the study information | 2016/10/05 |
| Last modified on | 2016/10/03 13:39:55 |
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Basic information
Public title
Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Acronym
Low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Scientific Title
Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Scientific Title:Acronym
Low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Region
| Japan |
Condition
Condition
Type 1 diabetes.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of low carbohydrate diet for basal insulin titration in type 1 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mean plasma glucose level, M value, MAGE
Key secondary outcomes
Incidence of hypoglycemia and hyperglycemia
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low carbohydrate diet
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 diabetes in our institution
Key exclusion criteria
1)Uncotroled hypertention(BPs>200mmHg/BPs>120mmHg(
2)serum Cre>2.0mg/dL(male), >1.5mg/dL(female)
3)Pregnant
4)Ketosis
5)HbA1c>12%
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Endocrinology and Metabolism 1
13-1 Takara-machi, Kanazawa, Ishikawa
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
| 2016 | Year | 10 | Month | 05 | 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
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 03 | Day |
Last modified on
| 2016 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027941
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/10/06 | 160107期間延長最終計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/10/06 | 160107期間延長最終.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/10/06 | data171006.xls |
Single case data URL
Value
https://center6.umin.ac.jp/ice/27941
