- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03354676
Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome? (ChildObes)
November 26, 2017 updated by: Alexandru Florin Rogobete
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
122
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria
Description
Inclusion Criteria:
- obese children (BMI> 95th percentile)
Exclusion Criteria:
- obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MetS+
Obese group with metabolic syndrome/Data processing from Patient Medical Files
|
Data processing from Patient Medical Files
|
|
MetS-
Obese group without metabolic syndrome/Data processing from Patient Medical Files
|
Data processing from Patient Medical Files
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defining obesity in the pediatric population
Time Frame: Weight and height were measured on day 1 of admission. Obesity was defined as a BMI > the 95th percentile.
|
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.
|
|
Leptin changes in the obese children with metabolic syndrome
Time Frame: Leptin levels were measured on day 1 of admission. Normal range was considered < 24ng/ml.
|
Evaluating leptin in the obese group with metabolic syndrome
|
Leptin levels were measured on day 1 of admission. Normal range was considered < 24ng/ml.
|
|
Adiponectin changes in the obese children with metabolic syndrome
Time Frame: 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.
|
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.
|
|
Assessing cardiovascular risk in the obese children with metabolic syndrome
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Beyazit F, Unsal 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. No abstract available.
- Lopez-Quintero A, Garcia-Zapien AG, Flores-Martinez SE, Diaz-Burke Y, Gonzalez-Sandoval CE, Lopez-Roa RI, Medina-Diaz E, Munoz-Almaguer ML, Sanchez-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.
- 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. 2018 Jul;55(4):422-429. doi: 10.1177/0004563217733286. Epub 2017 Nov 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 11, 2016
Primary Completion (ACTUAL)
August 11, 2017
Study Completion (ACTUAL)
September 10, 2017
Study Registration Dates
First Submitted
September 12, 2017
First Submitted That Met QC Criteria
November 26, 2017
First Posted (ACTUAL)
November 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 28, 2017
Last Update Submitted That Met QC Criteria
November 26, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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