We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121172
First Posted: May 12, 2010
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki
  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 Assimina Galli-Tsinopoulou, 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 ]
    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 ]
    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)
Groups/Cohorts
obese
obese subjects according to International Obesity Task Force criteria
lean

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 4, 2010
First Posted: May 12, 2010
Results First Submitted: March 15, 2016
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism