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

NCT03767608 | Completed

• 1 other identifier: AIEMPPDM2SM
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Pediatric Obesity

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Patients with type 2 diabetes mellitus

Patients diagnosed with T2DM according to the ADA

Lean healthy controls

Lean healthy controls

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

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

Monterrey, Nuevo León, 64710, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma were obtained from blood samples and were stored at -80°C

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Leticia Elizondo-Montemayor, MD

  Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

ME (1)