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
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
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
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
