Clinical trial NCT02797028: Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: Hyperuricemia
endothelial function
anthocyanidins
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2016-06-13
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

Detailed description: Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.

Eligibility criteria: Inclusion Criteria:

* Serum uric acid \>420μmol/L (7mg/dL) in male, \>360μmol/L (6mg/dL) in female identified as hyperuricemia patients.

Exclusion Criteria:

* Age more than 60 years and less than 30 years old;
* acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.

Primary outcomes:
measure: Measurement of serum uric acid levels in all patients
timeFrame: up to 1 months
Secondary outcomes:
measure: Measurement of advanced glycation end products and its receptor level in all patients
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: General Hospital of Guangzhou Military Command of People's Liberation Army
state: Guangdong
Study officials:
References:
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