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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01372800
Other study ID # xj050503
Secondary ID
Status Recruiting
Phase N/A
First received June 10, 2011
Last updated November 19, 2013
Start date May 2011

Study information

Verified date November 2011
Source Xijing Hospital
Contact Ling Tao, M.D Ph.D
Phone +86-15002955798
Email lingtao2006@gmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with major adverse events Major adverse events included but were not limited to death during the study caused by cardiovascular events or cerebrovascular events. 5 years Yes
Secondary blood routine, glucose and lipid profile; ECG; the tests mentioned above will be taken once per year 5 years No
Secondary serum adiponectin concentration, activity and isoforms serum adiponectin concentration, activity and isoforms will be monitored once per year. 5 years No
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