UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035924
Receipt number R000040922
Scientific Title Whether the lactate transport carrier is a biomarker for type 2 diabetes?
Date of disclosure of the study information 2019/02/18
Last modified on 2021/02/16 20:31:20

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Basic information

Public title

Whether the lactate transport carrier is a biomarker for type 2 diabetes?

Acronym

Whether the lactate transport carrier is a biomarker for type 2 diabetes?

Scientific Title

Whether the lactate transport carrier is a biomarker for type 2 diabetes?

Scientific Title:Acronym

Whether the lactate transport carrier is a biomarker for type 2 diabetes?

Region

Japan


Condition

Condition

Type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

In this study, we will clarify the relationship between the progression of Type2 diabetes and plasma lactate level and alanine.We also focus on polymorphisms of diabetes-related genes in MCT 1, 4, 11, and clarify how much MCT polymorphism affects diabetes progression. And we aim to help diagnosis and prevention of diabetes.

Basic objectives2

Others

Basic objectives -Others

The relationship between the progression of Type2 diabetes and plasma lactate level and alanine.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between plasma lactate, alanine and known diabetes marker (fasting blood glucose, HbA1c, insulin secretion ability etc.).

Key secondary outcomes

1. Correlation between plasma lactate, alanine and clinical information (age, sex, body weight, BMI, renal function, TG, LDL, HDL etc.).
2. Differences in the frequency of polymorphisms of diabetes-related genes in MCT 1, 4, 11 and the relationship between lactate and alanine and known diabetes markers.


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

(1) Aged 20 years or older at the time of acquiring written informed consent of clinical research. (2) Diabetes patient diagnosed by the report of the Japan Diabetes Society Committee on the classification and diagnostic criteria of diabetes mellitus.

Key exclusion criteria

(1) Patients diagnosed as type1 diabetes, or a pancreas-associated autoantibody such as glutamic acid decarboxylase antibody was positive. (2) Patients diagnosed as respiratory failure or serious liver failure. (3) Patients who were judged inappropriate as the subject by the research director.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Iseki

Organization

Hokkaido University Hospital

Division name

Department of Pharmacy

Zip code


Address

Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo 060-8648, Japan

TEL

011-706-3770

Email

ken-i@pharm.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Issei Higuchi

Organization

Hokkaido University Hospital

Division name

Department of Pharmacy

Zip code


Address

Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo 060-8648, Japan

TEL

011-706-3455

Homepage URL


Email

i-higuchi@huhp.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital, Department of Pharmacy

Institute

Department

Personal name



Funding Source

Organization

A Grant-in-Aid for Scientific Research (JSPS KAKENHI Grant)

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


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

北海道大学病院(北海道)/ Hokkaido University Hospital (Hokkaido, Japan)


Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

86

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

2014 Year 03 Month 25 Day

Date of IRB

2014 Year 03 Month 25 Day

Anticipated trial start date

2014 Year 05 Month 08 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

After informed consent, subjects participate only on the blood draw date (the early morning after more than 10 hours fasting).In this study, the number of blood draw does not increase because the target patient usually performs blood test at the same time as medical examination. The blood draw amount per one increase by 3 ml. Also, 5 maicrol of blood draw from only one point from the fingertip. Also, the necessary medical information is obtained from medical records of subjects.


Management information

Registered date

2019 Year 02 Month 18 Day

Last modified on

2021 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name