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The Relationship Among, Serum Uric Acid, Left Ventricular Hypertrophy and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03473951
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Cheng-Wei Liu, National Defense Medical Center, Taiwan

Brief Summary:
Hyperuricemia is associated with the prevalence of metabolic syndrome and cardiovascular risks in diverse of the population. Whether the dose-response effects on the prevalence of metabolic syndrome and cardiometabolic risks is unclear. The present study is conducted to investigate the relationship between serum uric acid and the prevalence metabolic syndrome and left ventricular hypertrophy.

Condition or disease Intervention/treatment
Hyperuricemia Healthy Diagnostic Test: Hyperuricemia

Detailed Description:
Apparently healthy individuals with an estimated screening number of approximately twenty-thousand individuals undergo an annual health exam in the investigators' hospital. The routine exam includes measurements of body height, body weight, blood pressure, visual and acoustic acuity, physical examinations, basic blood tests, urine analyses, chest radiography, and electrocardiography. The blood tests were performed after individuals fasted for at least eight hours. Individuals with any abnormal results underwent a clinical examination at an outpatient department for safety issues, ensuring the accuracy of the data. All data were registered prospectively. The investigators retrospectively collected data from the annual exam.

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Study Type : Observational
Estimated Enrollment : 18000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Dose-response Effect of Serum Uric Acid on the Prevalence and Electrocardiographic Left Ventricular Hypertrophy in the Apparently Healthy Individuals
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Group/Cohort Intervention/treatment
Hyperuricemia
Hyperuricemia is defined as a serum uric acid level of 7 mg/dl or more in men or 6 mg/dl or more in women
Diagnostic Test: Hyperuricemia
Hyperuricemia vs. normouricemia




Primary Outcome Measures :
  1. The prevalence of metabolic syndrome [ Time Frame: 1 day ]
    Based on the Taiwan criteria, metabolic syndrome must fulfill at least three of the five following criteria: 1) waist circumference more than 90 cm in men or more than 80 cm in women; 2) blood pressure of more than 130 / 85 mm Hg or already on anti-hypertensive medication; 3) fasting glucose of 100 mg/dl or more or already on anti-diabetic agents; 4) triglyceride level of 150 mg/dl or more or already on lipid lowering therapy for hypertriglyceridemia; 5) high-density lipoprotein cholesterol of 40 mg/dl or less in men or 50 mg/dl or less in women; the investigators also replaced the criterion of waist circumference by body mass index of 27 kg/m2 in the definition of metabolic syndrome.


Secondary Outcome Measures :
  1. Left ventricular hypertrophy - Cornell voltage criteria. [ Time Frame: 1 day ]
    Left ventricular hypertrophy is defined by Cornell voltage criteria.

  2. Left ventricular hypertrophy - Cornell voltage product. [ Time Frame: 1 day ]
    Left ventricular hypertrophy is defined by Cornell voltage product.

  3. Left ventricular hypertrophy - Sokolow-Lyon criteria. [ Time Frame: 1 day ]
    Left ventricular hypertrophy is defined by Sokolow-Lyon criteria.

  4. Left ventricular hypertrophy - Minnesota Code electrocardiographic classification. [ Time Frame: 1 day ]
    Left ventricular hypertrophy is defined by Minnesota Code electrocardiographic classification.

  5. Left ventricular hypertrophy - composite of Cornell voltage criteria, Cornell voltage product, Sokolow-Lyon criteria, Minnesota Code electrocardiographic classification. [ Time Frame: 1 day ]
    Any of above left ventricular hypertrophy criteria is counted as left ventricular hypertrophy.

  6. brief symptom rating scale-5 [ Time Frame: 1 day ]
    Brief symptom rating scale-5 consisted of five items with a total score of 0 to 20. Each items range from 0 to 4 in score, including difficult in falling asleep, anxiety (feeling tense or high-strung), hostility (feeling easily annoyed or irritated), interpersonal sensitivity (feeling inferior to others), depression (feeling depressed or in a low mood) in the past week. The summation of brief symptom rating scale-5 is further classified as normal (score of <6), mild mood disorder (score of 6-9), moderate mood disorder (score of 10-14), severe mood disorder (score of >14). Suicidal attempt is an additional item and the score >1 is considered as severe mood disorder.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Apparently healthy individuals routinely underwent the annual health exam.
Criteria

Inclusion Criteria:

  • Individuals with ages of 20-65 years underwent the annual health exam at the investigators' hospital.

Exclusion Criteria:

  • The individual had no data to define metabolic syndrome, including waist circumference, office blood pressure, serum uric acid, triglyceride, high-density lipoprotein cholesterol, fasting glucose.

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): NCT03473951


Contacts
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Contact: Liu +886-2-27642151 ext 671401 issac700319@gmail.com

Locations
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Taiwan
Tri-service General Hospital, songshan branch Recruiting
Taipei, Songshan Dist., Taiwan, 105
Contact: Liu, MD    +886-910682383    issac700319@gmail.com   
Principal Investigator: Cheng-Wei Liu, MD         
Sub-Investigator: Wei-Cheng Chang, MD         
Sponsors and Collaborators
National Defense Medical Center, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cheng-Wei Liu, Cardiologist, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03473951     History of Changes
Other Study ID Numbers: 2-106-05-148
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
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 hypertrophy

Additional relevant MeSH terms:
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Metabolic Syndrome
Hypertrophy
Hyperuricemia
Hypertrophy, Left Ventricular
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs