Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01121172
First received: May 4, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition
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.

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Serum apelin levels in obese children and adolescents [ Time Frame: cross-sectional study - at the time of collection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of G212A polymorphism of apelin receptor in obese children and adolescents [ Time Frame: cross-sectional study ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
obese
obese subjects according to International Obesity Task Force criteria
lean

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations
Greece
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

No publications provided

Responsible Party: Assimina Galli-Tsinopoulou, As. Professor in Pediatric Endocrinology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01121172     History of Changes
Other Study ID Numbers: 10012010
Study First Received: May 4, 2010
Last Updated: February 20, 2014
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014