UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027245 |
|---|---|
| Receipt number | R000031211 |
| Scientific Title | Investigation of Low Carbohydrate Diet (LCD) and Biomarkers |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2017/05/04 13:07:59 |
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Basic information
Public title
Investigation of Low Carbohydrate Diet (LCD) and Biomarkers
Acronym
Low Carbohydrate Diet (LCD) and Biomarkers
Scientific Title
Investigation of Low Carbohydrate Diet (LCD) and Biomarkers
Scientific Title:Acronym
Low Carbohydrate Diet (LCD) and Biomarkers
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
investigation of low carbohydrate diet (LCD) for several biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The levels of HbA1c and blood glucose and related several data, associated with several endocrine, metabolic and renal biomarkers
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
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low Carbohydarate Diet (LCD)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
diabetes mellitus (DM)
Key exclusion criteria
malignant diseases
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi BANDO, MD, PhD |
Organization
Medical Research
Division name
Medical Division
Zip code
Address
Nakashowa 1-61, Tokushima 770-0943 Japan
TEL
090-3187-2485
pianomed@bronze.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi BANDO, MD, PhD |
Organization
Medical Research
Division name
Medical Division
Zip code
Address
Nakashowa 1-61, Tokushima 770-0943 Japan
TEL
090-3187-2485
Homepage URL
pianomed@bronze.ocn.ne.jp
Sponsor or person
Institute
Medical Research, medical Division
Institute
Department
Personal name
Funding Source
Organization
Medical Research, medical Division
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 05 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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 | 05 | Month | 04 | Day |
Last modified on
| 2017 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031211
