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Hyperuricemia and Left Ventricular Diastolic Function

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ClinicalTrials.gov Identifier: NCT03495999
Recruitment Status : Terminated (The study interest was reached)
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cheng-Wei Liu, National Defense Medical Center, Taiwan

Brief Summary:
Metabolic syndrome and hyperuricemia were both associated with inflammation, leading to diversities of cardiovascular disease such as left ventricular diastolic dysfunction, but the relationship among these entities remained unclear. The aim of the present study focuses on the association among hyperuricemia, diastolic dysfunction and inflammatory biomarkers in apparently healthy individuals with metabolic syndrome

Condition or disease Intervention/treatment
Hyperuricemia Metabolic Syndrome Left Ventricular Diastolic Dysfunction Diagnostic Test: hyperuricemia

Detailed Description:
Apparently healthy individuals with metabolic syndrome were prospectively and consecutively enrolled since August 2017. Blood samples were obtained after participants are fasting for at least 12 hours, including serum uric acid, high-sensitivity C-reactive protein, high-sensitivity interleukin-6, tumor necrotizing factor alpha, fasting glucose, glycosylated hemoglobin, insulin, lipid profile, creatinine, alanine aminotransferase, sodium, potassium, and calcium. All echocardiographic parameters were measured in accordance with the American Society of Echocardiography guidelines.

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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Associations and Plausibility Among Left Ventricle Diastolic Function, Serum Uric Acid and Inflammatory Biomarkers in Individuals With Cardiometabolic Risks - A Prospective Observational Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normouricemia
Serum uric of 7mg/dl or less in men or 6mg/dl or less in women
Diagnostic Test: hyperuricemia
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

Hyperuricemia
Serum uric of 7mg/dl or more in men or 6mg/dl or more in women
Diagnostic Test: hyperuricemia
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women




Primary Outcome Measures :
  1. Left ventricle diastolic dysfunction with elevated left atrial pressure [ Time Frame: 1 day ]
    The contemporary definition of left ventricular diastolic dysfunction with elevated left atrial pressure is mainly >50% positive of the following criteria: (1) average E/e' ≥14 (2) left atrial volume index >34 ml/m2 (3) tricuspid regurgitation velocity >2.8 m/s


Secondary Outcome Measures :
  1. high-sensitivity C-reactive protein [ Time Frame: 1 week ]
    determined by Latex enhanced immunoturbidimetric,ADVIA 1800,ADVIA Chemistry XPT,Dimension RXL,SIEMENS,AU 640,Beckman Coulter

  2. high-sensitivity interleukin-6 [ Time Frame: 1 month ]
    determined by elisa enzyme-linked immunosorbent assay, R & D system

  3. tumor necrotizing factor alpha [ Time Frame: 1 month ]
    determined by elisa enzyme-linked immunosorbent assay


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Apparently healthy individuals with metabolic syndrome
Criteria

Inclusion Criteria:

  1. Age between 20 to 75 years
  2. Metabolic syndrome

Exclusion Criteria:

  1. Left ventricular ejection fraction <40%
  2. Severe valvular heart disease
  3. Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease
  4. Persistent or chronic atrial fibrillation
  5. Status post cardiac surgery, including coronary artery bypass surgery of valve intervention
  6. Status post intra-cardiac device implantation
  7. Chronic obstructive pulmonary disease
  8. Severe anemia
  9. An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome

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): NCT03495999


Locations
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Taiwan
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., Taiwan, 105
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Investigators
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Principal Investigator: Cheng-Wei Liu, M.D. Tri-service General hospital, Songshan branch, National defense medical center
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Responsible Party: Cheng-Wei Liu, Cardiologist, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03495999    
Other Study ID Numbers: 2-106-05-078
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng-Wei Liu, National Defense Medical Center, Taiwan:
Hyperuricemia
Metabolic syndrome
Left ventricular diastolic dysfunction
Inflammation
Additional relevant MeSH terms:
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Ventricular Dysfunction, Left
Metabolic Syndrome
Hyperuricemia
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases