YKL-40 and Complications in Type 2 Diabetes
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2011 | ||||
| Last Updated Date | July 5, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01387984 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | YKL-40 and Complications in Type 2 Diabetes | ||||
| Official Title ICMJE | Association Study of the Plasma Concentration of YKL-40 and Vascular Complications in Patients With Type 2 Diabetes | ||||
| Brief Summary | In this study, the investigators plan to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes. |
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| Detailed Description | It is well recognized now that diabetes mellitus is a systemic vasculopathy and causes various micro- and macrovascular complications. Vascular damage and endothelium dysfunction in diabetes mellitus involve a chronic inflammatory process via a complicated mechanism. YKL-40 is a 40 kD lectin molecule. It is secreted by various cells, including macrophages, vascular smooth muscle cells and giant cells, and the level of YKL-40 is found elevated in both acute (eg. infection) and chronic (eg. rheumatoid arthritis, systemic lupus erythematosus or cirrhosis of the liver) inflammatory processes. The plasma concentration of YKL-40 is elevated in the patients of type 2 diabetes mellitus compared with non-diabetic controls, and is associated with insulin resistance, fasting plasma glucose and plasma IL-6 concentrations. Furthermore, the concentration of YKL-40 is elevated and is associated with the severity of albuminuria in the patients of type 1 diabetes. The objective of this study is to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes, and to evaluate its potential as a biomarker for the vascular diabetic complications in patients with type 2 diabetes. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The type 2 diabetic patient who receives follow-up at NTUH diabetics caring network |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Type 2 diabetes mellitus | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 473 | ||||
| Completion Date | April 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01387984 | ||||
| Other Study ID Numbers ICMJE | 201002053R | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Chih-Hung Lin, MD, National Taiwan University Hospital Yun-Lin Branch | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | National Science Council, Taiwan | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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