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

Completed

• Conditions: Diabetes Mellitus, Type 2; Pediatric Obesity

• Registration Number: NCT03767608
• Lead Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey; 🇲🇽 Monterrey, Nuevo Leon, Mexico