NCT03495999

Brief 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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

April 3, 2018

Last Update Submit

April 11, 2018

Conditions

Keywords

HyperuricemiaMetabolic syndromeLeft ventricular diastolic dysfunctionInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • high-sensitivity C-reactive protein

    1 week

  • high-sensitivity interleukin-6

    1 month

  • tumor necrotizing factor alpha

    1 month

Study Arms (2)

Normouricemia

Serum uric of 7mg/dl or less in men or 6mg/dl or less in women

Diagnostic Test: hyperuricemia

Hyperuricemia

Serum uric of 7mg/dl or more in men or 6mg/dl or more in women

Diagnostic Test: hyperuricemia

Interventions

hyperuricemiaDIAGNOSTIC_TEST

serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

HyperuricemiaNormouricemia

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy individuals with metabolic syndrome

You may qualify if:

  • Age between 20 to 75 years
  • Metabolic syndrome

You may not qualify if:

  • Left ventricular ejection fraction \<40%
  • Severe valvular heart disease
  • Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease
  • Persistent or chronic atrial fibrillation
  • Status post cardiac surgery, including coronary artery bypass surgery of valve intervention
  • Status post intra-cardiac device implantation
  • Chronic obstructive pulmonary disease
  • Severe anemia
  • An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service General Hospital, songshan branch

Taipei, Songshan Dist., 105, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

HyperuricemiaMetabolic SyndromeVentricular Dysfunction, LeftInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Cheng-Wei Liu, M.D.

    Tri-service General hospital, Songshan branch, National defense medical center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 12, 2018

Study Start

August 1, 2017

Primary Completion

December 15, 2017

Study Completion

April 3, 2018

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations