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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name