ClinicalTrials.gg
CompletedNCT03354676ChildObesUpdated Nov 28, 2017

Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?

An observational study in Obesity, Metabolically Benign, sponsored by Alexandru Florin Rogobete. Completed. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Alexandru Florin Rogobete · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
122
Ages
4 Years to 18 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Obesity, Metabolically Benign

Keywords

  • adipokines, metabolic syndrome, obese children
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In context

Obesity, Metabolically Benign

27 studies on the registry are indexed under Obesity, Metabolically Benign; 8 are open to participants now.

This study's enrollment of 122 is close to the median of 134 across 10 observational studies indexed under Obesity, Metabolically Benign.

Browse Obesity, Metabolically Benign studies →

Lead sponsor

This is the only study on the registry with Alexandru Florin Rogobete as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • obese children (> 95th percentile)

Exclusion criteria

Exclusion Criteria:

  • obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMetS+

    Data processing from Patient Medical Files

  • OtherMetS-

    Data processing from Patient Medical Files

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Weight and height were measured on day 1 of admission. Obesity was defined as a BMI > the 95th percentile.

  2. Leptin changes in the obese children with metabolic syndrome

    Evaluating leptin in the obese group with metabolic syndrome

    Time frame: Leptin levels were measured on day 1 of admission. Normal range was considered < 24ng/ml.

  3. Adiponectin changes in the obese children with metabolic syndrome

    Evaluating adiponectin in the obese group 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.

  4. Assessing cardiovascular risk in the obese children with metabolic syndrome

    Evaluating hsCRP in the obese group 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

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 28890432 ↗
  • 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. PubMed 28886308 ↗
  • 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. PubMed 28882065 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in Aug 2017, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2017
First posted
Nov 28, 2017
StartActual
Mar 11, 2016
Primary completionActual
Aug 11, 2017
CompletionActual
Sep 10, 2017
Last update
Nov 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03354676
Lead sponsor
Alexandru Florin Rogobete
Collaborators
University of Medicine and Pharmacy "Victor Babes" Timisoara
Responsible party
Alexandru Florin Rogobete (MSc, PhDs, Clinical Researcher, Romanian Society of Anesthesia and Intensive Care) — Sponsor-investigator
First posted
Nov 28, 2017
Start date
Mar 11, 2016
Primary completion
Aug 11, 2017
Completion
Sep 10, 2017
Last update
Nov 28, 2017

Study contacts

Alexandru Florin Rogobete, PhDS
principal investigator · Romanian Society of Anesthesia and Intensive Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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