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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03473951
• Other study ID #: 2-106-05-148
• Status: Recruiting
• Start date: March 26, 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: National Defense Medical Center, Taiwan
• Contact: Liu
• Phone: +886-2-27642151
• Email: issac700319[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hypertrophy
• Hypertrophy, Left Ventricular
• Hyperuricemia
• Metabolic Syndrome

Intervention

Diagnostic Test:
• Hyperuricemia
Hyperuricemia vs. normouricemia

Locations

Country	Name	City	State
Taiwan	Tri-service General Hospital, songshan branch	Taipei	Songshan Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Left ventricular hypertrophy - Cornell voltage criteria.	Left ventricular hypertrophy is defined by Cornell voltage criteria.	1 day
Secondary	Left ventricular hypertrophy - Cornell voltage product.	Left ventricular hypertrophy is defined by Cornell voltage product.	1 day
Secondary	Left ventricular hypertrophy - Sokolow-Lyon criteria.	Left ventricular hypertrophy is defined by Sokolow-Lyon criteria.	1 day
Secondary	Left ventricular hypertrophy - Minnesota Code electrocardiographic classification.	Left ventricular hypertrophy is defined by Minnesota Code electrocardiographic classification.	1 day
Secondary	Left ventricular hypertrophy - composite of Cornell voltage criteria, Cornell voltage product, Sokolow-Lyon criteria, Minnesota Code electrocardiographic classification.	Any of above left ventricular hypertrophy criteria is counted as left ventricular hypertrophy.	1 day
Secondary	brief symptom rating scale-5	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