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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121172
Other study ID # 10012010
Secondary ID
Status Completed
Phase N/A
First received May 4, 2010
Last updated February 20, 2014
Start date May 2010
Est. completion date January 2014

Study information

Verified date February 2014
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate serum apelin levels as well as their possible association with G212A polymorphism of the apelin receptor in obese children and adolescents.

So far apelin has been reported to be involved in the pathophysiology of various heart diseases such as cardiomyopathies and heart failure. According to recent reports in adults apelin seems to be associated with impaired glucose metabolism, particularly in newly diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The researchers will try to investigate the role of this new adipokine in order to early detect and to prevent similar entities in childhood obesity.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date January 2014
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria:

- Obese children and adolescents (aged 2-16 years old)

Exclusion Criteria:

- Chronic diseases

- Hypothyroidism

- Medication

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Greece Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum apelin levels in obese children and adolescents cross-sectional study - at the time of collection No
Secondary Frequency of G212A polymorphism of apelin receptor in obese children and adolescents cross-sectional study No
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