UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019580 |
|---|---|
| Receipt number | R000022630 |
| Scientific Title | 13C-glucose breath test for evaluation of glucose metabolism |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2023/05/06 16:42:18 |
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Basic information
Public title
13C-glucose breath test for evaluation of glucose metabolism
Acronym
13C-glucose breath test for evaluation of glucose metabolism
Scientific Title
13C-glucose breath test for evaluation of glucose metabolism
Scientific Title:Acronym
13C-glucose breath test for evaluation of glucose metabolism
Region
| Japan |
Condition
Condition
healthy volunteer and diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of glucose metabolism in vivo by 13CO2 in breath, which
metabolite from intake of 13C-glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparison of 13CO2 in breath between healthy volunteer and diabetes mellitus at the time of breath test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
100mg of 13C-glucose + 50mL of water is administerd, thereafter breaths are collected.
The frequency of 13C-glucose administration is once.
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
Healthy volunteer (n=10)
Diabetes mellitus (n=30)
total (n=40)
Diabetes mellitus is defined as HbA1c>6.5% or taking anti-hypoglycemic agents
Key exclusion criteria
pregnancy and lactating women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Katagiri |
Organization
Tohoku University Hospital
Division name
Departments of Diabetes and Metabolism
Zip code
980
Address
Seiryo1-1, Aoba, Sendai, Miyagi
TEL
022-717-7611
hisyodm@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | Sawada |
Organization
Tohoku University Hospital
Division name
Departments of Diabetes and Metabolism
Zip code
980
Address
Seiryo1-1, Aoba, Sendai, Miyagi
TEL
022-717-7611
Homepage URL
ssawada@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants from the government to Tohoku university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital
Address
Seiryo1-1, Aoba, Sendai, Miyagi
Tel
022-717-7611
ssawada@med.tohoku.ac.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
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
16
Results
An association was found between carbon dioxide excretion and indices of abnormal glucose metabolism after oral administration of stable isotope-labeled glucose.
Results date posted
| 2023 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy individual
Participant flow
Healthy people were recruited through recruitment posters and other means.
Adverse events
None
Outcome measures
13C carbon dioxide in exhaled breath
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022630
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
