UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Acronym	Low-carbohydrate bread and postprandial hyperglycemia
Scientific Title	The efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Scientific Title:Acronym	Low-carbohydrate bread and postprandial hyperglycemia
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Peak blood glucose level after breakfast
Key secondary outcomes	The increase of blood glucose level and AUCduring 2hours after meal

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 bread (mean 0.22 g/g) 2 days
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Inpatients with type 2 diabetes whose blood glucose levels are stable during the study
Key exclusion criteria	!. Allergy to the bread 2. Unstable appetite 3.Gastrointestinal disease 4.Diseases which directly affect blood glucose levels 5. The patients whom the doctors defines as not suitable to the study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Suzuki
Organization	Fujita Health University
Division name	Department of Endocrinology and Metabolism, Department of Internal Medicine, School of Mediicine
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562939242
Email	aslapin@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Suzuki
Organization	Fujita Healtu University, School of Medicine
Division name	Division of Endocrinology and Metabolism, Department of Internal Medicine, School of Mediicine
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL	0562939242
Homepage URL
Email	aslapin@fujita-hu.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Department of Internal Medicine, Fujita health University School of Medicine
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Research Promotion and Support
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel	0562932111
Email	kenshien@fujita-hu.ac.jp

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	藤田医科大学医学部　内分泌・代謝内科学（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	35
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	Completed
Date of protocol fixation	2017 Year 08 Month 03 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2018 Year 01 Month 26 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 26 Day
Last modified on	2019 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035403