NCT03354676

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

September 12, 2017

Last Update Submit

November 26, 2017

Conditions

Keywords

adipokines, metabolic syndrome, obese children

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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

Study Arms (2)

MetS+

Obese group with metabolic syndrome/Data processing from Patient Medical Files

Other: MetS+

MetS-

Obese group without metabolic syndrome/Data processing from Patient Medical Files

Other: MetS-

Interventions

MetS-OTHER

Data processing from Patient Medical Files

MetS-

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria

You may qualify if:

  • obese children (BMI\> 95th percentile)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28890432BACKGROUND
  • 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.

    PMID: 28886308BACKGROUND
  • 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.

    PMID: 28882065BACKGROUND

MeSH Terms

Conditions

Obesity, Metabolically BenignMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Alexandru Florin Rogobete, PhDS

    Romanian Society of Anesthesia and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc, PhDs, Clinical Researcher

Study Record Dates

First Submitted

September 12, 2017

First Posted

November 28, 2017

Study Start

March 11, 2016

Primary Completion

August 11, 2017

Study Completion

September 10, 2017

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share