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Completed

NCT Number: NCT03767608

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey

Monterrey, Nuevo León, 64710, Mexico

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)

    Time frame: 1 day

    Correlation of irisin levels and anthropometric parameters in children with T2DM

  2. Correlation of irisin levels and anthropometric parameters in healthy control children

    Time frame: 1 day

    Correlation of irisin levels and anthropometric parameters in healthy control children

  3. Correlation of irisin levels and cytokines levels in children with T2DM

    Time frame: 1 day

    Correlation of irisin levels and cytokines levels in children with T2DM

  4. Correlation of irisin levels and C reactive protein levels in healthy control children

    Time frame: 1 day

    Correlation of irisin levels and C reactive protein levels in healthy control children

  5. Comparison between groups

    Time frame: 1 day

    Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls

Sponsors and collaborators

Lead sponsor

Instituto Tecnologico y de Estudios Superiores de Monterey

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2018
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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