UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low Carbohydrate Diet (LCD) in the light of MAGE and M value
Title of the study (Brief title)	Low Carbohydrate Diet (LCD) with MAGE and M value
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	investigation of the changes of blood glucose in low carbohydrate diet (LCD)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	evaluation of the changes of blood glucose
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 carbohydrate 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
Key exclusion criteria	diabetes mellitus associated with severe diabetic complications
Target sample size	24

Research contact person
Name of lead principal investigator	Hiroshi BANDO, MD, PhD
Organization	Medical Research
Division name	Medical Division
Address	Nakashowa 1-61, Tokushima 770-0943 Japan
TEL	090-3187-2485
Email	pianomed@bronze.ocn.ne.jp

Public contact
Name of contact person	Hiroshi BANDO, MD, PhD
Organization	Medical Research
Division name	Medical Division
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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 13 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 05 Day
Anticipated trial start date	2016 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 10 Day
Last modified on	2016 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029006