HyperuricemiaNCT03473951
The Relationship Among, Serum Uric Acid, Left Ventricular Hypertrophy and Metabolic Syndrome
An observational study of Hyperuricemia and Healthy, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Healthy
- What is being tested?
- Hyperuricemia
- How many people
- 18,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2018to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently healthy individuals routinely underwent the annual health exam.
Who may be able to join
- Individuals with ages of 20-65 years underwent the annual health exam at the investigators' hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., 105
Liu, MD, +886-910682383, issac700319@gmail.com
Cheng-Wei Liu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperuricemia, Healthy
- Being tested
- Hyperuricemia
- Keywords
- Hyperuricemia, Metabolic syndrome, Left ventricular hypertrophy
- Medical subject headings
- Hyperuricemia, Metabolic Syndrome, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperuricemiaDiagnostic test
Hyperuricemia vs. normouricemia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Hyperuricemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (6)
Left ventricular hypertrophy - Cornell voltage criteria.
Left ventricular hypertrophy is defined by Cornell voltage criteria.
Measured: 1 day
Left ventricular hypertrophy - Cornell voltage product.
Left ventricular hypertrophy is defined by Cornell voltage product.
Measured: 1 day
Left ventricular hypertrophy - Sokolow-Lyon criteria.
Left ventricular hypertrophy is defined by Sokolow-Lyon criteria.
Measured: 1 day
Left ventricular hypertrophy - Minnesota Code electrocardiographic classification.
Left ventricular hypertrophy is defined by Minnesota Code electrocardiographic classification.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start26 Mar 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Wei Liu, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473951
- Sponsor's protocol ID
- 2-106-05-148
- Status last verified
- Jun 2020
- First submitted
- 15 Mar 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34518090Liu 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.
PubMed 33618920Liu 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.
PubMed 30545672
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-response Effect of Serum Uric Acid on the Prevalence and Electrocardiographic Left Ventricular Hypertrophy in the Apparently Healthy Individuals
- ClinicalTrials.gov ID
- NCT03473951
- Acronym / sponsor ID
- 2-106-05-148
- Conditions
- Hyperuricemia, Healthy
- Keywords
- Hyperuricemia, Metabolic syndrome, Left ventricular hypertrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperuricemia | – | Diagnostic Test: HyperuricemiaHyperuricemia is defined as a serum uric acid level of 7 mg/dl or more in men or 6 mg/dl or more in women |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy individuals routinely underwent the annual health exam.
Key inclusion criteria (1 listed)
- Individuals with ages of 20-65 years underwent the annual health exam at the investigators' hospital.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperuricemiaHyperuricemia vs. normouricemia | Diagnostic test | Hyperuricemia |
Primary outcome
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.
6 secondary outcomes
Left ventricular hypertrophy - Cornell voltage criteria.
Time frame: 1 day
Left ventricular hypertrophy - Cornell voltage product.
Time frame: 1 day
Left ventricular hypertrophy - Sokolow-Lyon criteria.
Time frame: 1 day
Left ventricular hypertrophy - Minnesota Code electrocardiographic classification.
Time frame: 1 day
Left ventricular hypertrophy - composite of Cornell voltage criteria, Cornell voltage product, Sokolow-Lyon criteria, Minnesota Code electrocardiographic classification.
Time frame: 1 day
brief symptom rating scale-5
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 34518090Tu 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.
- Derived from this study: PubMed 33618920Liu 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.
- Derived from this study: PubMed 30545672Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia and Healthy, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu (+886-2-27642151 ext. 671401, issac700319@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of metabolic syndrome (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.