Clinical trial NCT03767608: Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus
Official title: Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Pediatric Obesity
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 Mexican children and adolescents aged 7-17 (20 boys and 20 girls) 20 children and adolescents diagnosed with T2DM and 20 healthy controls

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)
timeFrame: 1 day
measure: Correlation of irisin levels and anthropometric parameters in healthy control children
timeFrame: 1 day
measure: Correlation of irisin levels and cytokines levels in children with T2DM
timeFrame: 1 day
measure: Correlation of irisin levels and C reactive protein levels in healthy control children
timeFrame: 1 day
measure: Comparison between groups
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey
state: Nuevo Leon
Study officials:
affiliation: Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud
name: Leticia Elizondo-Montemayor, MD
role: PRINCIPAL_INVESTIGATOR
References: