UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010663 |
|---|---|
| Receipt number | R000012471 |
| Scientific Title | The efficacy and safety of low-carbohydrate diet for Japanese patients of type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/05/10 |
| Last modified on | 2017/01/04 18:28:14 |
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Basic information
Public title
The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Acronym
The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Scientific Title
The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Scientific Title:Acronym
The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of HbA1c
Key secondary outcomes
Body weight
Frequency of hypoglycemia
Lipid metabolism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-carbohydrate diet
Interventions/Control_2
Japanese diabetic diet
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
Patient whose HbA1c has not been improved more than 0.5%, without practicing Japanese diabetic diet properly.
Key exclusion criteria
Patient whose HbA1c is less than 7.4%.
Patient whose BMI is less than 22.
Patient who eats carbohydrate less than 130
g/day before registration.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sato, Junko |
Organization
Juntendo University Graduate School
Division name
Department of Metabolism and Endocrinology
Zip code
Address
3-1-3 Hongo Bunkyoku Tokyo
TEL
03-3813-3111
jsato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sato, Junko |
Organization
Juntendo University Graduate School
Division name
Department of Metabolism and Endocrinology
Zip code
Address
3-1-3 Hongo Bunkyoku Tokyo
TEL
03-3813-3111
Homepage URL
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School
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
| 2013 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012471
