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YKL-40 and Complications in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01387984
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Study Description
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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.

Condition or disease
Type 2 Diabetes Mellitus

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.


Study Design
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Study Type : Observational
Actual Enrollment : 473 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association Study of the Plasma Concentration of YKL-40 and Vascular Complications in Patients With Type 2 Diabetes
Study Start Date : April 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Type 2 diabetes mellitus


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The type 2 diabetic patient who receives follow-up at NTUH diabetics caring network
Criteria

Inclusion Criteria:

  • Clear consciousness
  • type 2 diabetic patient
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387984


Locations
Taiwan
National Taiwan University Hospital Yun-Lin Branch
Douliu City, Yunlin County, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chih-Hung Lin, M.D. National Taiwan University Hospital, Yun-Lin Branch
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Chih-Hung Lin, MD, National Taiwan University Hospital Yun-Lin Branch
ClinicalTrials.gov Identifier: NCT01387984     History of Changes
Other Study ID Numbers: 201002053R
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: June 2011

Keywords provided by National Taiwan University Hospital:
Type 2 diabetes mellitus
Diabetic complications
YKL-40

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
CHI3L1 protein, human
Growth Substances
Physiological Effects of Drugs