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

June 4, 2020 updated by: Cheng-Wei Liu, National Defense Medical Center, Taiwan

The Dose-response Effect of Serum Uric Acid on the Prevalence and Electrocardiographic Left Ventricular Hypertrophy in the Apparently Healthy Individuals

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Songshan Dist.
      • Taipei, Songshan Dist., Taiwan, 105
        • Recruiting
        • Tri-service General Hospital, songshan branch
        • Contact:
        • Principal Investigator:
          • Cheng-Wei Liu, MD
        • Sub-Investigator:
          • Wei-Cheng Chang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Apparently healthy individuals routinely underwent the annual health exam.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular hypertrophy - Cornell voltage criteria.
Time Frame: 1 day
Left ventricular hypertrophy is defined by Cornell voltage criteria.
1 day
Left ventricular hypertrophy - Cornell voltage product.
Time Frame: 1 day
Left ventricular hypertrophy is defined by Cornell voltage product.
1 day
Left ventricular hypertrophy - Sokolow-Lyon criteria.
Time Frame: 1 day
Left ventricular hypertrophy is defined by Sokolow-Lyon criteria.
1 day
Left ventricular hypertrophy - Minnesota Code electrocardiographic classification.
Time Frame: 1 day
Left ventricular hypertrophy is defined by Minnesota Code electrocardiographic classification.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-106-05-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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