UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024346 |
|---|---|
| Receipt number | R000028032 |
| Scientific Title | Investigation of short-term comparison between low carbohydrate diet (LCD) and calorie-restriction (CR) |
| Date of disclosure of the study information | 2016/10/12 |
| Last modified on | 2016/10/09 20:52:54 |
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Basic information
Public title
Investigation of short-term comparison between low carbohydrate diet (LCD) and calorie-restriction (CR)
Acronym
The short-term effect of low carbohydrate diet (LCD)
Scientific Title
Investigation of short-term comparison between low carbohydrate diet (LCD) and calorie-restriction (CR)
Scientific Title:Acronym
The short-term effect of low carbohydrate diet (LCD)
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of short-term effect of low carbohydrate diet (LCD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The points of evaluation are before study and after study (12-14 days).
The primary outcome are M value which is calcuated from fluctuation of blood glucose and mean amplitude of glycemic excursions (MAGE).
Key secondary outcomes
Key secondary outcomes include HbA1c, average of blood glucose, mean amplitude of glycemic excursions (MAGE), urinary C-peptide excretion, lipids and renal function.
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
As to the specific meal, calorie-restiction (CR) is given in day 0-2, and low carbohydrate diet (LCD) is given in days 3-14.
CR has 1400 kcal/day with 60% of carbohydrate, and LCD has 1400 kcal/day with 12% of carbohydrate.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects include the person with diabetes mellitus who can understand and obey the protocol.
Key exclusion criteria
The subjects who can not understand or obey the protocol.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi BANDO, MD, PhD, FACP |
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, FACP |
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
Japan
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 | 12 | 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 | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 15 | 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
| 2016 | Year | 10 | Month | 09 | Day |
Last modified on
| 2016 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028032
