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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03495999
Other study ID # 2-106-05-078
Secondary ID
Status Terminated
Phase
First received April 3, 2018
Last updated April 11, 2018
Start date August 1, 2017
Est. completion date April 3, 2018

Study information

Verified date April 2018
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Metabolic syndrome and hyperuricemia were both associated with inflammation, leading to diversities of cardiovascular disease such as left ventricular diastolic dysfunction, but the relationship among these entities remained unclear. The aim of the present study focuses on the association among hyperuricemia, diastolic dysfunction and inflammatory biomarkers in apparently healthy individuals with metabolic syndrome


Description:

Apparently healthy individuals with metabolic syndrome were prospectively and consecutively enrolled since August 2017. Blood samples were obtained after participants are fasting for at least 12 hours, including serum uric acid, high-sensitivity C-reactive protein, high-sensitivity interleukin-6, tumor necrotizing factor alpha, fasting glucose, glycosylated hemoglobin, insulin, lipid profile, creatinine, alanine aminotransferase, sodium, potassium, and calcium. All echocardiographic parameters were measured in accordance with the American Society of Echocardiography guidelines.


Recruitment information / eligibility

Status Terminated
Enrollment 67
Est. completion date April 3, 2018
Est. primary completion date December 15, 2017
Accepts healthy volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

1. Age between 20 to 75 years

2. Metabolic syndrome

Exclusion Criteria:

1. Left ventricular ejection fraction <40%

2. Severe valvular heart disease

3. Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease

4. Persistent or chronic atrial fibrillation

5. Status post cardiac surgery, including coronary artery bypass surgery of valve intervention

6. Status post intra-cardiac device implantation

7. Chronic obstructive pulmonary disease

8. Severe anemia

9. An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
hyperuricemia
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

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 Left ventricle diastolic dysfunction with elevated left atrial pressure The contemporary definition of left ventricular diastolic dysfunction with elevated left atrial pressure is mainly >50% positive of the following criteria: (1) average E/e' =14 (2) left atrial volume index >34 ml/m2 (3) tricuspid regurgitation velocity >2.8 m/s 1 day
Secondary high-sensitivity C-reactive protein determined by Latex enhanced immunoturbidimetric,ADVIA 1800,ADVIA Chemistry XPT,Dimension RXL,SIEMENS,AU 640,Beckman Coulter 1 week
Secondary high-sensitivity interleukin-6 determined by elisa enzyme-linked immunosorbent assay, R & D system 1 month
Secondary tumor necrotizing factor alpha determined by elisa enzyme-linked immunosorbent assay 1 month
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