UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029178 |
|---|---|
| Receipt number | R000033333 |
| Scientific Title | Investigation of factors increase in serum lactate level in diabetic patients. |
| Date of disclosure of the study information | 2017/09/17 |
| Last modified on | 2024/03/23 11:17:25 |
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Basic information
Public title
Investigation of factors increase in serum lactate level in diabetic patients.
Acronym
Investigation of factors increase in serum lactate level in diabetic patients.
Scientific Title
Investigation of factors increase in serum lactate level in diabetic patients.
Scientific Title:Acronym
Investigation of factors increase in serum lactate level in diabetic patients.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a physiological action of lactic acid, accumulating of triglyceride by insulin in adipocytes is presumed. In diabetic state, serum lactic acid level increases, inflammation in muscle cells and anti-inflammatory effect in the liver have been reported, however the pathological significance is not clear yet. In this study, in order to clarify the pathophysiology significance of serum lactate increase in diabetic patients, statistical analysis is performed with various factors including patient serum analysis and body composition test. The objective is to use the results obtained by analysis as the basis for diet exercise therapy, diabetes treatment strategy and new approach to health promotion through clinical evidence.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the pathophysiological significance of serum lactate increase in diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fasting serum lactic acid level
Key secondary outcomes
HbA1c,fasting blood glucose,1,5-AG,insulin,C-peptide,AST,ALT,r-GTP,ALP,LDH,bilirubin,BUN,Cr,eGFR,albumin,LDL,TG,HDL,MCP-1,adiponectin,ketone body,HOMA-R,fib4-index,body composition test
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
fasting blood glucose under 250mg/dl
fasting C-peptide under 1.0ng/ml
HbA1c under 10%
Patients taking diet and exercise therapy
Age from 20 years old to under 80
Key exclusion criteria
patients undergoing acute treatment for diabetes (diabetes ketoacidosis, diabetic coma, etc.)
type 1 diabetes
acute phase of cerebral cardiovascular disease (within 6 months)
heart failure (NYHA classification III,IV)
severe renal impairment (Ccr <60)
severe liver dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Minori |
| Middle name | |
| Last name | Ishitobi |
Organization
Kyorin University
Division name
Department of Internal medicine (3)
Zip code
1810004
Address
Shinkawa 6-20-2, Mitaka, Tokyo
TEL
04-2247-5511
minori221dancing@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Minori |
| Middle name | |
| Last name | Ishitobi |
Organization
Kyorin University
Division name
Department of Internal medicine (3)
Zip code
1810004
Address
Shinkawa 6-20-2, Mitaka, Tokyo
TEL
04-2247-5511
Homepage URL
minori221dancing@yahoo.co.jp
Sponsor or person
Institute
Kyorin University,
Department of Internal medicine (3)
Institute
Department
Personal name
Ishitobi Minori
Funding Source
Organization
Kyorin University,
Department of Internal medicine (3)
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
Kyorin University, Department of Internal medicine (3)
Address
Shinkawa 6-20-2, Mitaka-city, Tokyo
Tel
04-2247-5511
minori221dancing@yahoo.co.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 | 09 | Month | 17 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HbA1c,fasting blood glucose,1,5-AG,insulin,C-peptide,AST,ALT,r-GTP,ALP,LDH,bilirubin, BUN,Cr,eGFR,albumin,LDL,TG,HDL,MCP-1,adiponectin,ketone body,HOMA-R,fib4-index,body composition test
Management information
Registered date
| 2017 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033333
