Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines

NCT ID: NCT02797028

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo capsule

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Anthocyanidins capsule

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule.

Group Type: EXPERIMENTAL

Anthocyanidins capsule

Intervention Type: DIETARY_SUPPLEMENT

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Allopurinol

The experimental group taking allopurinol.

Group Type: EXPERIMENTAL

Allopurinol

Intervention Type: DRUG

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Interventions

Anthocyanidins capsule

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Intervention Type: DIETARY_SUPPLEMENT

Allopurinol

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

Yuan Zhang

Doctor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Guangzhou Military Command of People's Liberation Army

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Dai

Role: CONTACT

daihui66@sina.com

020-36653321

Yuan Zhang

Role: CONTACT

1035834805@qq.com

020-61653566

Facility Contacts

Hui Dai

Role: primary

daihui66@sina.com

020-36653321

Yuan Zhang

Role: backup

1035834805@qq.com

020-61653566

References

Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.

Reference Type: BACKGROUND

PMID: 15198963 (View on PubMed)

Gimbrone MA Jr. Endothelial dysfunction and atherosclerosis. J Card Surg. 1989 Jun;4(2):180-3. doi: 10.1111/j.1540-8191.1989.tb00275.x.

Reference Type: BACKGROUND

PMID: 2519996 (View on PubMed)

Verma S, Anderson TJ. Fundamentals of endothelial function for the clinical cardiologist. Circulation. 2002 Feb 5;105(5):546-9. doi: 10.1161/hc0502.104540. No abstract available.

Reference Type: BACKGROUND

PMID: 11827916 (View on PubMed)

D'Marco L, Garcia I, Vega C. [Uric acid, atherosclerosis and vascular calcifications in chronic kidney disease]. Invest Clin. 2012 Mar;53(1):52-9. Spanish.

Reference Type: BACKGROUND

PMID: 22524108 (View on PubMed)

Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008 Oct 23;359(17):1811-21. doi: 10.1056/NEJMra0800885. No abstract available.

Reference Type: BACKGROUND

PMID: 18946066 (View on PubMed)

Li C, Han L, Levin AM, Song H, Yan S, Wang Y, Wang Y, Meng D, Lv S, Ji Y, Xu X, Liu X, Wang Y, Zhou L, Miao Z, Mi QS. Multiple single nucleotide polymorphisms in the human urate transporter 1 (hURAT1) gene are associated with hyperuricaemia in Han Chinese. J Med Genet. 2010 Mar;47(3):204-10. doi: 10.1136/jmg.2009.068619. Epub 2009 Oct 14.

Reference Type: BACKGROUND

PMID: 19833602 (View on PubMed)

Other Identifiers

No. 81402671

Identifier Type: -

Identifier Source: org_study_id