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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese | obese subjects according to International Obesity Task Force criteria | ||
| lean |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents | Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group | First day after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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40 obese children 40 obese adolescents 50 lean children 50 lean adolescents
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki | Thessaloniki | 56403 | Greece |
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| ID | Title | Description |
|---|---|---|
| FG000 | Obese | obese children and adolescents according to International Obesity Task Force criteria |
| FG001 | Lean | lean children and adolescents matched for age and gender to the obese group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obese | obese children and adolescents according to International Obesity Task Force criteria |
| BG001 | Lean | lean children and adolescents matched for age and gender to the obese group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Apelin Levels | Apelin levels were measured in serum of participants, in fasting state | Posted | Median | Full Range | ng/ml | First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obese | obese children and adolescents according to International Obesity Task Force criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assimina Galli-Tsinopoulou, As.Professor of Pediatric Endocrinology | 4th Department of Pediatrics, School of Medicine, Aristotle University of Thessaloniki | 00302310991537 | agalli@auth.gr |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| 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 | Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group. | Posted | Number | participants | First day after enrollment |
|
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Lean | lean children and adolescents matched for age and gender to the obese group | 0 | 90 | 0 | 90 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Title |
|---|
| Measurements |
|---|
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