Diabetes Mellitus Type 2, Insulin Resistance, Obesity
Conditions
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.
Interventions
None listed
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Obese children and adolescents (aged 2-16 years old)
Exclusion criteria
* Chronic diseases * Hypothyroidism * Medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Apelin Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents | First day after enrollment | Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obese obese children and adolescents according to International Obesity Task Force criteria | 90 |
| Lean lean children and adolescents matched for age and gender to the obese group | 90 |
| Total | 180 |
Baseline characteristics
| Characteristic | Obese | Lean | Total |
|---|---|---|---|
| Age, Continuous | 11.6 years | 11.7 years | 11.6 years |
| Region of Enrollment Greece | 90 participants | 90 participants | 180 participants |
| Sex: Female, Male Female | 56 Participants | 47 Participants | 103 Participants |
| Sex: Female, Male Male | 34 Participants | 43 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Obese | Serum Apelin Levels | 1.45 ng/ml |
| Lean | Serum Apelin Levels | 1.91 ng/ml |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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
Population: Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Obese | Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents | GG | 48 participants |
| Obese | Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents | AA | 7 participants |
| Obese | Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents | GA | 35 participants |
p-value: 0.232Chi-squared