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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354676
Other study ID # 12870
Secondary ID
Status Completed
Phase N/A
First received September 12, 2017
Last updated November 26, 2017
Start date March 11, 2016
Est. completion date September 10, 2017

Study information

Verified date November 2017
Source Romanian Society of Anesthesia and Intensive Care
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to investigate the relationship between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese children, and to determine whether these adipokines are significant markers in defining metabolic syndrome in pediatric population


Description:

The idea that adipose tissue is just a form of energy storage has changed dramatically in recent years. Currently, adipose tissue is considered to be a true endocrine gland that fulfills multiple roles in regulating different biological functions. Communication between adipose tissue and the rest of the systems is accomplished through bioactive mediators (adipokines) Adipokines control energy homeostasis and are involved in metabolic, endocrine and immunological processes.This study aimed to investigate the relationship between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese children, and to determine whether these adipokines are significant markers in defining metabolic syndrome in pediatric population.The current retrospective observational study was conducted at the "Louis Turcanu" Emergency Hospital Timisoara over a period of one year, from July 2013 and June 2014. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Endocrinology, Diabetology and Cardiology department.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date September 10, 2017
Est. primary completion date August 11, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- obese children (BMI> 95th percentile)

Exclusion Criteria:

- obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MetS+
Data processing from Patient Medical Files
MetS-
Data processing from Patient Medical Files

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alexandru Florin Rogobete University of Medicine and Pharmacy "Victor Babes" Timisoara

References & Publications (3)

Bagherniya M, Khayyatzadeh SS, Heidari Bakavoli AR, Ferns GA, Ebrahimi M, Safarian M, Nematy M, Ghayour-Mobarhan M. Serum high-sensitive C-reactive protein is associated with dietary intakes in diabetic patients with and without hypertension: a cross-sectional study. Ann Clin Biochem. 2017 Jan 1:4563217733286. doi: 10.1177/0004563217733286. [Epub ahead of print] — View Citation

Beyazit F, Ünsal MA. Obesity and insulin resistance are significant predictors of serum leptin levels. J Turk Ger Gynecol Assoc. 2017 Sep 1;18(3):158-159. doi: 10.4274/jtgga.2017.0027. — View Citation

López-Quintero A, García-Zapién AG, Flores-Martínez SE, Díaz-Burke Y, González-Sandoval CE, Lopez-Roa RI, Medina-Díaz E, Muñoz-Almaguer ML, Sánchez-Corona J. Contribution of polymorphisms in the LEP, LEPR and RETN genes on serum leptin and resistin levels in young adults from Mexico. Cell Mol Biol (Noisy-le-grand). 2017 Aug 30;63(8):10-18. doi: 10.14715/cmb/2017.63.8.3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Defining obesity in the pediatric population Measuring weight in kilograms and height in meters in order to calculate BMI and represent it on the percentile graph. Weight and height were measured on day 1 of admission. Obesity was defined as a BMI > the 95th percentile.
Primary Leptin changes in the obese children with metabolic syndrome Evaluating leptin in the obese group with metabolic syndrome Leptin levels were measured on day 1 of admission. Normal range was considered < 24ng/ml.
Primary Adiponectin changes in the obese children with metabolic syndrome Evaluating adiponectin in the obese group with metabolic syndrome Adiponectin levels were measured on day 1 of admittance in children aged between 4 and18 years. Levels 4-26 mcg/ml were defined as normal values.
Primary Assessing cardiovascular risk in the obese children with metabolic syndrome Evaluating hsCRP in the obese group with metabolic syndrome hsCRP levels were measured on day 1 of admittance in children aged between 4 and 18 years. Normal levels were considered between 0.1-2.8 mg/l
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