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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026476
Receipt No. 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 2017/04/20

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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
Email 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
Email shomu@h-c-h.jp

Sponsor
Institute Hokuriku Central Hospital
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded

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
2017 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030408

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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