UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038086 |
|---|---|
| Receipt number | R000043406 |
| Scientific Title | Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2022/01/15 04:54:29 |
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Basic information
Public title
Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Acronym
Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Scientific Title
Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Scientific Title:Acronym
Cross-sectional study for correlation between blood ketone body and breath acetone concentration in patients with diabetes using breath acetone checker
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between blood ketone body and breath acetone concentration in patients with diabetes using Fat-burning Monitor(FM-001)
Basic objectives2
Others
Basic objectives -Others
Evaluation of correlation between blood ketone bodies and breath acetone concentration measured with Fat-burning Monitor (FM-001)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficient between breath acetone and blood total ketone body concentration and its 95% confidence interval.
Key secondary outcomes
Linear regression equation to calculating blood total ketone body concentration from breath acetone concentration.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among diabetic patients admitted to Diabetic Center of St. Marianna University Hospital, patients whose urinary ketone bodies were positive at the time of application for hospitalization.
Key exclusion criteria
1.Patients requiring intensive care unit management with diabetic ketoacidosis or hyperglycemic hyperosmolar state.
2.Patients who detected blood alcohol at the time of hospitalization.
3.Patients who cannot useFM-001 by difficulty in controlling exhalation due to respiratory disease, cerebrovascular disease or other disease.
4.Patients with severe infections, before and after surgery, and severe trauma.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nagai |
| Middle name | |
| Last name | Yoshio |
Organization
St.marianna university
Division name
endcrinology and metabolism
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
TEL
044-977-8111
ynagai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Tsunemi |
Organization
St.marianna university
Division name
endcrinology and metabolism
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
TEL
044-977-8111
Homepage URL
shingo.tsunemi@marianna-u.ac.jp
Sponsor or person
Institute
St.marianna university
Institute
Department
Personal name
Funding Source
Organization
St.marianna university
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
St.marianna university
Address
2-16-1 Sugao, Miyamae-ward, Kawasaki-city, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the correlation between blood ketone body concentration and breath acetone concentration in diabetic patients who were positive for urine ketone when they were admitted to hospital, by using Fat-burning Monitor(FM-001)
Management information
Registered date
| 2019 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043406
