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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767608
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey

Study Description
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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.

Condition or disease
Diabetes Mellitus, Type 2 Pediatric Obesity

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 Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus
Study Start Date : January 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with type 2 diabetes mellitus
Patients diagnosed with T2DM according to the ADA
Lean healthy controls
Lean healthy controls


Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Serum and plasma were obtained from blood samples and were stored at -80°C

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767608


Locations
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Mexico
Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo Leon, Mexico, 64710
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Investigators
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Principal Investigator: Leticia Elizondo-Montemayor, MD Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud
More Information
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Responsible Party: Leticia Elizondo-Montemayor, Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT03767608    
Other Study ID Numbers: AIEMPPDM2SM
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight