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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035924
Receipt No. 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 2019/02/18

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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
Institute Hokkaido University Hospital, Department of Pharmacy
Institute
Department

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 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 No longer recruiting
Date of protocol fixation
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 08 Day
Last follow-up date
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
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.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


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