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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024346
Receipt No. 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

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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
Email 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
Email pianomed@bronze.ocn.ne.jp

Sponsor
Institute Medical Research, Medical Division
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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