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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029390
Receipt No. R000033588
Scientific Title Study for the effect of the blood glucose change of the appropriate glucide noodles using Flash Glucose Monitoring (FGM)
Date of disclosure of the study information 2017/10/11
Last modified on 2020/05/10

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Basic information
Public title Study for the effect of the blood glucose change of the appropriate glucide noodles using Flash Glucose Monitoring (FGM)
Acronym Study for the effect of the blood glucose change of the appropriate glucide noodles.
Scientific Title Study for the effect of the blood glucose change of the appropriate glucide noodles using Flash Glucose Monitoring (FGM)
Scientific Title:Acronym Study for the effect of the blood glucose change of the appropriate glucide noodles.
Region
Japan

Condition
Condition type 1 diabetes mellitus, type 2 diabetes mellitus, glucose tolerance normal person
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine a blood glucose profile after the appropriate glucide noodles intake using blood FGM.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Postcibal blood glucose Area Under the Curve(AUC)
Key secondary outcomes 1)Postcibal blood glucose AUC of less than70mg/dl
2)Postcibal mean blood glucose level
3)change of insulin dose(type 1 diabetes mellitus)
4)Effect on satisfaction for the diet and dietary behavior by the questionary survey

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Appropriate glucide noodles
Interventions/Control_2 Common glucide noodles
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 1)patients with written informed consent
2)patients with type 2 diabetes that HbA1c is 6.0~9.0%
Key exclusion criteria 1)patients with severe hepatic dysfunction, renal dysfunction, heart failure, 2)patients with a history of hypersensitivity of the food to use in this study, 3)pregnancy, 4)patients who received one of glinide or a-glucosidase inhibitor or SGLT2 inhibitor,5)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Takeuchi
Organization Sapporo diabetes, thyroid clinic
Division name Sapporo diabetes, thyroid clinic
Zip code 060-0807
Address Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-707-1024
Email jun_takeuchi@me.com

Public contact
Name of contact person
1st name Jun
Middle name
Last name Takeuchi
Organization Sapporo diabetes, thyroid clinic
Division name Sapporo diabetes, thyroid clinic
Zip code 060-0807
Address Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-707-1024
Homepage URL
Email info@sdtc.jp

Sponsor
Institute Sapporo diabetes, thyroid clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sapporo Medical Associations ERB(Ethical Review Board)
Address 19-1-1, Odorinishi, Chuo-ku Sapporo-shi, Hokkaido, 060-8581, Japan
Tel 011-611-4181
Email chiken@spmed.or.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 さっぽろ糖尿病・甲状腺クリニック(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 11 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 20
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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
2017 Year 09 Month 12 Day
Anticipated trial start date
2017 Year 10 Month 11 Day
Last follow-up date
2019 Year 10 Month 11 Day
Date of closure to data entry
2019 Year 10 Month 11 Day
Date trial data considered complete
2019 Year 10 Month 11 Day
Date analysis concluded
2019 Year 10 Month 11 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033588

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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