Obesity, Metabolically BenignChildObesNCT03354676
Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?
An observational study of Obesity, Metabolically Benign, run by Alexandru Florin Rogobete.
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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Obesity, Metabolically Benign
- What is being tested?
- MetS+ and MetS-
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2016to 10 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria
Who may be able to join
- obese children (BMI> 95th percentile)
Who cannot join
- obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
About this study
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.
- Conditions
- Obesity, Metabolically Benign
- Being tested
- MetS+, MetS-
- Keywords
- adipokines, metabolic syndrome, obese children
- Medical subject headings
- Obesity, Metabolically Benign, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetS+Other
Data processing from Patient Medical Files
MetS-Other
Data processing from Patient Medical Files
| Study group | Role | What they receive |
|---|---|---|
| MetS+ | Obese group with metabolic syndrome/Data processing from Patient Medical Files Receives: Other: MetS+ | |
| MetS- | Obese group without metabolic syndrome/Data processing from Patient Medical Files Receives: Other: MetS- |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start11 Mar 2016
- Primary completion11 Aug 2017
- Study completion10 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, Metabolically BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandru Florin Rogobete
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Responsible party
- Sponsor-investigator, Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care
- Investigators
- Alexandru Florin Rogobete, PhDS, Principal investigator, Romanian Society of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354676
- Sponsor's protocol ID
- 12870
- Acronym
- ChildObes
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28890432Lopez-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 28886308Bagherniya 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?
- ClinicalTrials.gov ID
- NCT03354676
- Acronym / sponsor ID
- ChildObes / 12870
- Conditions
- Obesity, Metabolically Benign
- Keywords
- adipokines, metabolic syndrome, obese children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Alexandru Florin RogobeteUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 10 Sep 2017 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetS+ | – | Other: MetS+Obese group with metabolic syndrome/Data processing from Patient Medical Files |
| MetS- | – | Other: MetS-Obese group without metabolic syndrome/Data processing from Patient Medical Files |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria
Key inclusion criteria (1 listed)
- obese children (BMI> 95th percentile)
Key exclusion criteria (1 listed)
- obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetS+Data processing from Patient Medical Files | Other | MetS+ |
| MetS-Data processing from Patient Medical Files | Other | MetS- |
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 28890432Beyazit 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.
- Background: PubMed 28886308Lopez-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.
- Background: PubMed 28882065Bagherniya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Florin Rogobete, PhDS principal investigator
Romanian Society of Anesthesia and Intensive Care
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Metabolically Benign, run by Alexandru Florin Rogobete.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.