UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029390 |
|---|---|
| Receipt number | 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 | 2023/04/07 09:54:02 |
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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
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
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
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
20
Results
This study demonstrated that LSHFP can reduce postprandial glucose elevation compared with SP in both healthy participants and patients with T2DM.
Results date posted
| 2021 | Year | 10 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten healthy volunteers who did not have T2DM and were otherwise healthy (5 men, 5 women) and 10 patients with T2DM (5 men, 5 women) participated in the study. Regarding the background characteristics, the patients with T2DM had age of 62.3+-7.1 years, HbA1c level of 7.0%+-0.9%, and BMI of 26.1+-6.9 kg/m2, while the healthy volunteers had age of 37.4+-10.0 years, HbA1c level of 5.1%+-0.3%, and BMI of 20.4+-2.7 kg/m2
Participant flow
Ten healthy volunteers who did not have T2DM and were otherwise healthy (5 men; 5 women) and 10 patients with T2DM (5 men; 5 women) participated in the study. All participants completed the full crossover study.
Adverse events
No participants developed hypoglycemia or gastrointestinal symptoms during the study period. No adverse events were observed.
Outcome measures
The 4h-gluAUC for LSHFP (137.6+-42.2 mg/dLh) was significantly smaller than the 4h-gluAUC for rice (201.7+-38.7 mg/dLh) (p=0.001) and SP (178.5+-59.2 mg/dLh) (p=0.020).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033588
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