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Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

This study has been completed.
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki Identifier:
First received: May 4, 2010
Last updated: April 13, 2016
Last verified: April 2016

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.

Insulin Resistance
Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)in Obese Children and Adolescents.

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Serum Apelin Levels [ Time Frame: First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning ] [ Designated as safety issue: No ]
    Apelin levels were measured in serum of participants, in fasting state

Secondary Outcome Measures:
  • Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents [ Time Frame: First day after enrollment ] [ Designated as safety issue: No ]
    Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group

Enrollment: 180
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
obese subjects according to International Obesity Task Force criteria


Ages Eligible for Study:   2 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
40 obese children 40 obese adolescents 50 lean children 50 lean adolescents

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic diseases
  • Hypothyroidism
  • Medication
  Contacts and Locations
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Please refer to this study by its identifier: NCT01121172

Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

Responsible Party: Assimina Galli-Tsinopoulou, As. Professor in Pediatric Endocrinology, Aristotle University Of Thessaloniki Identifier: NCT01121172     History of Changes
Other Study ID Numbers: 10012010 
Study First Received: May 4, 2010
Results First Received: March 15, 2016
Last Updated: April 13, 2016
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism processed this record on October 26, 2016