UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025445
Receipt number R000029284
Scientific Title 13C-glucose breath test for evaluation of glucose metabolism in patients with fatty liver
Date of disclosure of the study information 2017/01/10
Last modified on 2020/06/30 13:20:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

13C-glucose breath test for evaluation of glucose metabolism in patients with fatty liver

Acronym

13C-glucose breath test for evaluation of glucose metabolism in patients with fatty liver

Scientific Title

13C-glucose breath test for evaluation of glucose metabolism in patients with fatty liver

Scientific Title:Acronym

13C-glucose breath test for evaluation of glucose metabolism in patients with fatty liver

Region

Japan


Condition

Condition

fatty liver disease

Classification by specialty

Gastroenterology Endocrinology and Metabolism

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

13CO2 in breath 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

fatty liver disease

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 Universuty Hospital

Division name

Dept of Diabetes and Metabolism

Zip code

980

Address

Seiryo 1-1, Aoba, Sendai, Miyagi

TEL

022-717-7611

Email

hisyodm@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Shojiro
Middle name
Last name Sawada

Organization

Tohoku Universuty Hospital

Division name

Dept of Diabetes and Metabolism

Zip code

980

Address

Seiryo 1-1, Aoba, Sendai, Miyagi

TEL

022-717-7611

Homepage URL


Email

ssawada@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Grants from the goverment 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

Address

Seiryo 1-1, Aoba, Sendai, Miyagi

Tel

022-717-7611

Email

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

2017 Year 01 Month 10 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

14

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 02 Month 27 Day

Date of IRB

2017 Year 03 Month 01 Day

Anticipated trial start date

2017 Year 03 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

2016 Year 12 Month 27 Day

Last modified on

2020 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029284


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name