Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The objective of this study was to investigate the association of irisin with inflammatory markers as well with metabolic and anthropometric parameters in children and adolescents with type 2 diabetes mellitus compared with healthy controls.

Detailed Description
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Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria were recruited and compared to healthy controls. The participants will undergo: vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory rate) anthropometric variables measurement (BMI, weight, waist circumference, hip circumference, body fat %) laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin After statistical analyses the investigators will compare the relationship of irisin and the inflammatory profile and the anthropometric parameters of diabetic patients versus lean controls.

Official Title
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Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2, Pediatric Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Have been previously diagnosed with T2DM according to the American Diabetes Association (ADA) criteria . Healthy controls were required to have: Normal weight according to the Centers for Disease Control and Prevention (CDC) criteria. No metabolic abnormalities on blood samples No previously diagnosed cardiometabolic diseases Not been using antihypertensive, lipid or glucose lowering medications Exclusion Criteria: Disapproval by the children's physician due to any at-risk medical condition known by the parents Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes mellitus<br>Patients diagnosed with T2DM according to the ADA | |
| Lean healthy controls<br>Lean healthy controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM) | Correlation of irisin levels and anthropometric parameters in children with T2DM | 1 day | 
| Correlation of irisin levels and anthropometric parameters in healthy control children | Correlation of irisin levels and anthropometric parameters in healthy control children | 1 day | 
| Correlation of irisin levels and cytokines levels in children with T2DM | Correlation of irisin levels and cytokines levels in children with T2DM | 1 day | 
| Correlation of irisin levels and C reactive protein levels in healthy control children | Correlation of irisin levels and C reactive protein levels in healthy control children | 1 day | 
| Comparison between groups | Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls | 1 day |