UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Title of the study (Brief title)	An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To compare the pleiotropic effect including blood glucose fluctuation on patients with type 2 diabetes between low carbohydrate diet only breakfast and only dinner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose fluctuation(AUC,M values,MAGE)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	10% carbohydrate diet only breakfast for two days
Interventions/Control_2	10% carbohydrate diet only dinner for two days
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with type 2 diabetes 2. Patients who are admitted to the purpose of glycemic control more than one week
Key exclusion criteria	1.Mediacal history and/or complication of diabetic ketoasidosis. 2.Mediacal history and/or complication of diabetic hypoglycemia. 3.Severe infection, before and after surgery or severe trauma. 4.Treatment with glucocorticoid. 5.Uncontrolled hypertension(systric blood pressure>160 mmHg or diastolic blood pressure >100 mmHg) 6.Proliferative retinopathy or maculopathy. 7.History of maligmancy. 8.Severe health problems not suitable for the study. 9.Women with possibility of pregnancy, or during pregnancy and lactation. 10.Cases that physicians deem inappropriate as the target of the test.
Target sample size	40

Research contact person
Name of lead principal investigator	Toshinari TAKAMURA
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Disease control and homeostasis
Address	13-1 Takara-machi,kanazawa,Ishikawa,Japan
TEL	076-265-2234
Email	ttakamura@m-kanazawa.jp

Public contact
Name of contact person	Toshinari Takamura
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Disease control and homeostasis
Address	13-1 Takara-machi,kanazawa,Ishikawa,Japan
TEL	076-265-2234
Homepage URL
Email	ttakamura@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Kanazawa University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 04 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 04 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	2013 Year 04 Month 03 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012166