Serum Adiponectin in Chinese Population and Its Correlation to Cardiovascular and Cerebrovascular Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372800
First received: June 10, 2011
Last updated: November 19, 2013
Last verified: November 2011
  Purpose

Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to these diseases.


Condition
Myocardial Infarction
Cerebral Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Adiponectin Concentration, Activity and Isoforms in Chinese Population and Its Correlation to Cardiovascular and Cerebrovascular Diseases

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Number of Participants with major adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Major adverse events included but were not limited to death during the study caused by cardiovascular events or cerebrovascular events.


Secondary Outcome Measures:
  • blood routine, glucose and lipid profile; ECG; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    the tests mentioned above will be taken once per year

  • serum adiponectin concentration, activity and isoforms [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    serum adiponectin concentration, activity and isoforms will be monitored once per year.


Biospecimen Retention:   None Retained

blood


Estimated Enrollment: 30000
Study Start Date: May 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Detailed Description:

Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes, anti-inflammatory, vascular protective, and anti-ischemic properties. Since its 1995 discovery, Ad has garnered considerable attention for its role in diabetic and cardiovascular pathology. Clinical observations have demonstrated the association of hypoadiponectinemia in patients with obesity, cardiovascular disease, and insulin resistance. There is growing evidence supporting Ad can act as a novel risk factor for cardiovascular and cerebrovascular injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to cardiovascular and cerebrovascular diseases.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

volunteer

Criteria

Inclusion Criteria:

  • available for 5 years of follow-up study

Exclusion Criteria:

  • Death caused other than cardiovascular and cerebralvascular diseases till the study ends
  • Floating Population
  • Pregnancy, lactation, or child bearing women
  • Tumor
  • Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
  • Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
  • Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372800

Contacts
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, M.D Ph.D    +86-15002955798    lingtao2006@gmail.com   
Principal Investigator: Ling Tao, M.D Ph.D         
Sponsors and Collaborators
Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01372800     History of Changes
Other Study ID Numbers: xj050503
Study First Received: June 10, 2011
Last Updated: November 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
adiponectin
cardiovascular diseases
cerebrovascular diseases

Additional relevant MeSH terms:
Cerebrovascular Disorders
Infarction
Myocardial Infarction
Cerebral Infarction
Stroke
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014