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The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome (URIC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01818505
First received: March 21, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose
Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, the investigators will analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. The investigators expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.

Condition
Antiphospholipid Syndrome
Endothelial Dysfunction
Hyperuricemia
Gout
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • development of metabolic syndrome or cardiovascular events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute myocardial infarct or stroke [ Time Frame: 36 months or more ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
serum

Estimated Enrollment: 210
Study Start Date: March 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gouty arthritis
Patient with gouty arthritis
Asymptomatic hyperuricemia
Patient with asymptomatic hyperuricemia
OA without hyperuricemia
Patient of osteoarthritis but without hyperuricemia and gout

Detailed Description:

Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, we'll analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/ asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. We expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.

Patient eligibility:

  1. Patients with gout
  2. Patients with asymptomatic hyperuricemia
  3. Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria: Patients younger than 20 years old
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General population
Criteria

Inclusion Criteria:

  1. Patient with gouty arthritis
  2. Patient with asymptomatic hyperurecemia
  3. Patient of osteoarthritis but without hyperuricemia and gout

Exclusion Criteria:

1.Patient younger than 20 y/o.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818505

Locations
Taiwan
National Taiwan University Hospital Yun-Lin Branch
Dou-Liou City, Yun-Lin County, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Min Kuo, MD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01818505     History of Changes
Other Study ID Numbers: URIC 
Study First Received: March 21, 2013
Last Updated: April 11, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
antiphospholipid syndrome
gouty arthritis
Hyperuricemia
metabolic syndrome
osteoarthritis
cardiovascular co-morbidities

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Gout
Hyperuricemia
Antiphospholipid Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Antibodies
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016