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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003280
Receipt No. R000003972
Scientific Title Lipid-Related Residual Risk of Microvascular Complications in Patients with Type 2 Diabetes
Date of disclosure of the study information 2010/03/03
Last modified on 2012/09/05

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Basic information
Public title Lipid-Related Residual Risk of Microvascular Complications in Patients with Type 2 Diabetes
Acronym Lipid-Related Residual Risk of Microvascular Complications in Patients with Type 2 Diabetes
Scientific Title Lipid-Related Residual Risk of Microvascular Complications in Patients with Type 2 Diabetes
Scientific Title:Acronym Lipid-Related Residual Risk of Microvascular Complications in Patients with Type 2 Diabetes
Region
Japan

Condition
Condition type 2 diabetes
dyslipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine, in type 2 diabetes patients with LDL cholesterol (LDL-C)<130 mg/dl treated or not treated with statin therapy and presenting with at least one microvascular complication (diabetic retinopathy, maculopathy, or nephropathy):
1) The prevalence of low plasma levels of HDL cholesterol(HDL-C) and/or elevated plasma levels of triglycerides.
2) Whether low HDL-C and/or elevated TG levels are associated with a significant risk of microvascular complication of diabetes after adjustment on other risk factors.
Basic objectives2 Others
Basic objectives -Others The incidence of neuropathy and the predictive value of the lipid profile will be assessed.
The prevalence of retinopathy in patients with nephropathy and vice versa will be assessed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) The prevalence of low plasma levels of HDL cholesterol(HDL-C) and/or elevated plasma levels of triglycerides.
2) Whether low HDL-C and/or elevated TG levels are associated with a significant risk of microvascular complication of diabetes after adjustment on other risk factors.
Key secondary outcomes

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria At least one documented microvascular complication:
Diabetic retinopathy
Diabetic maculopathy
Diabetic nephropathy
LDL-C<130 mg/dl with or without statin therapy
Key exclusion criteria Type 1 diabetes, congestive heart failure, active cancer treatment, organ transplant recipients, end stage renal disease, autoimmune diseases, HIV, substance abuse, severe liver disease, Non-diabetic kidney disease, except if accompanied by a known microvascular complication of diabetes
Target sample size 174

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3795
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute The residual risk reduction initiative foundation
Institute
Department

Funding Source
Organization The residual risk reduction initiative foundation
Organization
Division
Category of Funding Organization Outside Japan
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 慶應大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 03 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 Completed
Date of protocol fixation
2009 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information Demographic data
Personal history
Microvascular complications diagnosis and outcome
Lipid parameters
Other laboratory parameters within the 6 months prior to the index visit
Pharmacological and other treatments

Management information
Registered date
2010 Year 03 Month 02 Day
Last modified on
2012 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003972

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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