UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032148 |
|---|---|
| Receipt number | 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 | 2019/10/08 09:44:19 |
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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 | 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
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
info@sdtc.jp
Sponsor or person
Institute
Sapporo diabetes, thyroid clinic
Institute
Department
Personal name
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
Sapporo Medical Associations ERB Ethical Review Board
Address
19-1-1, Odorinishi, Chuo-ku Sapporo-shi, Hokkaido, 060-8581, Japan
Tel
011-611-4181
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 07 | Day |
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
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
