UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of short-term comparison between low carbohydrate diet (LCD) and calorie-restriction (CR)
Title of the study (Brief title)	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	Hiroshi BANDO, MD, PhD, FACP
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, FACP
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	Japan

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 10 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 25 Day
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

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Publication of results	Unpublished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