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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032148
Receipt No. R000036672
Scientific Title Study for the effect of the blood glucose change of the appropriate glucide noodles (Ramen) using Free continuous Glucose Monitoring System (FGM).
Date of disclosure of the study information 2018/04/07
Last modified on 2018/04/07

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

Condition
Condition 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)Blood glucose change index after the test meal intake
(2)Hypoglycemic level, frequency, severity after the test meal intake
(3)Effect on satisfaction for the diet and dietary behavior by the questionary survey
(4)Comparison between AUC and subjects background

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 (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 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Takeuchi
Organization Sapporo diabetes, thyroid clinic
Division name Sapporo diabetes, thyroid clinic
Zip code
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
Middle name
Last name Jun Takeuchi
Organization Sapporo diabetes, thyroid clinic
Division name Sapporo diabetes, thyroid clinic
Zip code
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 Sapporo diabetes, thyroid clinic
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
Address
Tel
Email

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
2018 Year 04 Month 07 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
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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Using FGM, we evaluate a blood glucose change after the appropriate glucide noodles (ramen) intake.

Management information
Registered date
2018 Year 04 Month 07 Day
Last modified on
2018 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036672

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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