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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029178
Receipt No. 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 2017/09/17

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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
Middle name
Last name Minori Ishitobi
Organization Kyorin University
Division name Department of Internal medicine (3)
Zip code
Address Shinkawa 6-20-2, Mitaka, Tokyo
TEL 04-2247-5511
Email minori221dancing@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minori Ishitobi
Organization Kyorin University
Division name Department of Internal medicine (3)
Zip code
Address Shinkawa 6-20-2, Mitaka, Tokyo
TEL 04-2247-5511
Homepage URL
Email minori221dancing@yahoo.co.jp

Sponsor
Institute Kyorin University,
Department of Internal medicine (3)
Institute
Department

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
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

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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 30 Day
Last follow-up date
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
2017 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033333

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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