UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026476 |
|---|---|
| Receipt number | R000030408 |
| Scientific Title | Real-life glycemic profiles in non-diabetic subjects assessed by flash glucose monitoring. |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2020/04/01 18:13:58 |
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Basic information
Public title
Real-life glycemic profiles in non-diabetic subjects assessed by flash glucose monitoring.
Acronym
Glycemic profiles in non-diabetic subjects.
Scientific Title
Real-life glycemic profiles in non-diabetic subjects assessed by flash glucose monitoring.
Scientific Title:Acronym
Glycemic profiles in non-diabetic subjects.
Region
| Japan |
Condition
Condition
NGT IGT
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimated the standard values for postprandial glucose in non-diabetic subjects
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average time spent above different plasma glucose thresholds in 24 hours.
Key secondary outcomes
Glucose tolerance assessed by oral glucose tolerance test
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
non-diabetic subjects with fasting plasma glucose < 95 mg/dl
Key exclusion criteria
post-gastrectomy state, positive for hepatitis virus markers, taking anti-cancer drugs or replacement of any hormones, fasting plasma glucose <95 mg/dl, BMI,18.5 or >25.0 kg/m2, subject to skin problems, pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Oka |
Organization
Hokuriku CentralHospital
Division name
Internal Medicine
Zip code
Address
123 Nodera Oyabe Toyama, 932-8503
TEL
0766-67-1150
ririoka@goo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hana Mikuni |
Organization
Hokuriku Central Hospital
Division name
Department of general affairs
Zip code
Address
123 Nodera Oyabe Toyama, 932-8503
TEL
0766-67-1150
Homepage URL
shomu@h-c-h.jp
Sponsor or person
Institute
Hokuriku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
The Juzen Medical Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
1)mean time of elevated glucose over the different thresholds in NGT and IGT.
2)analysis of correlation of peak value and time of postprandial glucose with oral glucose tolerance test.
Management information
Registered date
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030408
| Research Plan | |
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| 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 |
