NCT03473951

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

March 15, 2018

Last Update Submit

June 4, 2020

Conditions

Keywords

HyperuricemiaMetabolic syndromeLeft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • The prevalence of metabolic syndrome

    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 Outcomes (6)

  • Left ventricular hypertrophy - Cornell voltage criteria.

    1 day

  • Left ventricular hypertrophy - Cornell voltage product.

    1 day

  • Left ventricular hypertrophy - Sokolow-Lyon criteria.

    1 day

  • Left ventricular hypertrophy - Minnesota Code electrocardiographic classification.

    1 day

  • Left ventricular hypertrophy - composite of Cornell voltage criteria, Cornell voltage product, Sokolow-Lyon criteria, Minnesota Code electrocardiographic classification.

    1 day

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

HyperuricemiaDIAGNOSTIC_TEST

Hyperuricemia vs. normouricemia

Hyperuricemia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy individuals routinely underwent the annual health exam.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service General Hospital, songshan branch

Taipei, Songshan Dist., 105, Taiwan

RECRUITING

Related Publications (3)

  • Tu CM, Wei TE, Tseng GS, Chen CC, Liu CW. Serum uric acid is associated with incident metabolic syndrome independent of body shape index and body roundness index in healthy individuals. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3142-3151. doi: 10.1016/j.numecd.2021.07.008. Epub 2021 Jul 24.

  • Liu CW, Ke SR, Tseng GS, Wu YW, Hwang JJ. Elevated serum uric acid is associated with incident hypertension in the health according to various contemporary blood pressure guidelines. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1209-1218. doi: 10.1016/j.numecd.2021.01.003. Epub 2021 Jan 12.

  • Liu CW, Chen KH, Tseng CK, Chang WC, Wu YW, Hwang JJ. The dose-response effects of uric acid on the prevalence of metabolic syndrome and electrocardiographic left ventricular hypertrophy in healthy individuals. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):30-38. doi: 10.1016/j.numecd.2018.10.001. Epub 2018 Oct 16.

MeSH Terms

Conditions

HyperuricemiaMetabolic SyndromeHypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, Anatomical

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

March 26, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations