UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003280 |
|---|---|
| Receipt number | 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 18:40:59 |
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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
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
Sponsor or person
Institute
The residual risk reduction initiative foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003972
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
