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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767608
• Other study ID #: AIEMPPDM2SM
• Status: Completed
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2018
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 1, 2017
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pediatric Obesity

Locations

Country	Name	City	State
Mexico	Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Correlation of irisin levels and anthropometric parameters in healthy control children	Correlation of irisin levels and anthropometric parameters in healthy control children	1 day
Primary	Correlation of irisin levels and cytokines levels in children with T2DM	Correlation of irisin levels and cytokines levels in children with T2DM	1 day
Primary	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
Primary	Comparison between groups	Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls	1 day