Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

NCT01121172 | Completed Results

• 1 other identifier: 10012010
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Insulin Resistance; Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Serum Apelin Levels

  Apelin levels were measured in serum of participants, in fasting state

  First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning

Secondary Outcomes (1)

• Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents

  First day after enrollment

Study Arms (2)

obese

obese subjects according to International Obesity Task Force criteria

lean

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

40 obese children 40 obese adolescents 50 lean children 50 lean adolescents

You may qualify if:

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

You may not qualify if:

• Chronic diseases
• Hypothyroidism
• Medication

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Thessaloniki, 56403, Greece

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Assimina Galli-Tsinopoulou, As.Professor of Pediatric Endocrinology
• Organization: 4th Department of Pediatrics, School of Medicine, Aristotle University of Thessaloniki

agalli@auth.gr

00302310991537

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: As. Professor in Pediatric Endocrinology

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2014
• Last Updated: May 19, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-04

Locations

GR (1)