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CompletedNCT01121172Updated May 19, 2016Results posted

Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

An observational study in Obesity, Insulin Resistance and Diabetes Mellitus Type 2, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 2 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
180
Ages
2 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Insulin Resistance
  • Diabetes Mellitus Type 2
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 180 is above the median of 80 across 339 observational studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
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

Exclusion Criteria:

  • Chronic diseases
  • Hypothyroidism
  • Medication
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
180 participants (actual)

Groups and cohorts

  • obese

    obese subjects according to International Obesity Task Force criteria

  • lean
06

What researchers measure

Primary outcomes

  1. Serum Apelin Levels

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

    Time frame: 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

    Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group

    Time frame: First day after enrollment

07

Results

Posted May 19, 2016

Participant flow

Participant flow — Overall Study
MilestoneObeseLean
Started9090
Completed9090
Not completed00

Outcome measures

PrimarySerum Apelin Levels

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

Time frame:
First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning
Reported as:
Median · ng/ml
Serum Apelin Levels
ng/mlObeseLean
Serum Apelin Levels1.45 (0.63 to 4.54)1.91 (0.55 to 4.71)
Statistical analysis
  • Obese vs Lean · Wilcoxon (Mann-Whitney) · p = 0.001Non parametric test
SecondaryFrequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents

Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group

Time frame:
First day after enrollment
Reported as:
Number · participants
Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents
participantsObese Group
GG48
AA7
GA35
Statistical analysis
  • Obese Group · Chi-squared · p = 0.232Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution

Adverse events

Collected over This is a cross-sectional non intervantional, observation study. Time for reporting adverse events was the first day after enrollment, during which blood samples were collected.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Obese—0/90 (0%)0/90 (0%)
Lean—0/90 (0%)0/90 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)ObeseLeanTotal
Median11.6 (2.6 to 16.5)11.7 (3.3 to 17.8)11.6 (2.6 to 17.8)
Sex: Female, Male
Sex: Female, Male(Participants)ObeseLeanTotal
Female5647103
Male344377
Region of Enrollment
Region of Enrollment(participants)ObeseLeanTotal
Greece9090180
08

Study locations

1 site
  • Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
    Thessaloniki, 56403, Greece
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01121172
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Assimina Galli-Tsinopoulou (As. Professor in Pediatric Endocrinology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
May 12, 2010
Start date
May 2010
Primary completion
Jun 2012
Completion
Jan 2014
Results posted
May 19, 2016
Last update
May 19, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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