Obesity, Metabolically BenignNCT03435978
Effect of Diet and Physical Activity on Adipokines
An observational study of Obesity, Metabolically Benign, run by Louis Turcanu Emergency Hospital for Children.
Trial summary
The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obesity, Metabolically Benign
- What is being tested?
- MetS+ and MetS-
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 3 Jan 2018
- 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 5 to 18 years
- All sexes
- 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
Official title: Effect of Three-month Diet and Physical Activity on Adipokines and Inflammatory Status in Children With Metabolic Syndrome
The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).
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.The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).
The investigators tested the hypothesis that long-term lifestyle changes and moderate weight loss would reduce the plasma concentrations of adipokines involved in inflammation, angiogenesis, and chemotaxis and would increase adiponectin concentrations.
Material and methods:
A prospective study was conducted over a period of 1 year, between January 2016 and December 2016, on 66 cases of obesity in children diagnosed at the Louis Ţurcanu Emergency Hospital for Children Timisoara. The patients diagnosed with MetS were put on diet and physical exercise for 3 months.
- Conditions
- Obesity, Metabolically Benign
- Being tested
- MetS+, MetS-
- Keywords
- diet, 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+Behavioural
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: Behavioral: 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 after three months of diet and physical activity.
Measured: Leptin levels were measured on day 1 of admission and after three months. Normal range was considered < 24ng/ml.
Adiponectin changes in the obese children with metabolic syndrome
Evaluating adiponectin in the obese group with metabolic syndrome after three months of diet and physical activity.
Measured: Adiponectin levels were measured on day 1 of admittance and after three months in children aged between 4 and 18 years. Levels 4-26 mcg/ml were defined as normal values.
hsCRP changes in the obese children with metabolic syndrome
Evaluating hsCRP in the obese group with metabolic syndrome after three months of diet and physical activity.
Measured: hsCRP levels were measured on day 1 of admittance and after three months 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 posted19 Feb 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Turcanu Emergency Hospital for Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Responsible party
- Principal investigator, Ramona Stroescu, Louis Turcanu Emergency Hospital for Children
- Investigators
- Mihai Gafencu, Md,PhD, Principal investigator, Louis Turcanu Emergency Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435978
- Sponsor's protocol ID
- 13200
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 19 Feb 2018
- 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 28890432Bagherniya 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three-month Diet and Physical Activity on Adipokines and Inflammatory Status in Children With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03435978
- Acronym / sponsor ID
- 13200
- Conditions
- Obesity, Metabolically Benign
- Keywords
- diet, metabolic syndrome, obese children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Louis Turcanu Emergency Hospital for ChildrenUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 19 Feb 2018 (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.
The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).
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.The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to determine whether these adipokines are significant markers in defining MetS in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity CRP (hs-CRP).
The investigators tested the hypothesis that long-term lifestyle changes and moderate weight loss would reduce the plasma concentrations of adipokines involved in inflammation, angiogenesis, and chemotaxis and would increase adiponectin concentrations.
Material and methods:
A prospective study was conducted over a period of 1 year, between January 2016 and December 2016, on 66 cases of obesity in children diagnosed at the Louis Ţurcanu Emergency Hospital for Children Timisoara. The patients diagnosed with MetS were put on diet and physical exercise for 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetS+ | – | Behavioral: 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
- 5 to 18 years
- Sex
- All
- 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+ | Behavioural | 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 and after three months. Normal range was considered < 24ng/ml.
Evaluating leptin in the obese group with metabolic syndrome after three months of diet and physical activity.
Adiponectin changes in the obese children with metabolic syndrome
Time frame: Adiponectin levels were measured on day 1 of admittance and after three months in children aged between 4 and 18 years. Levels 4-26 mcg/ml were defined as normal values.
Evaluating adiponectin in the obese group with metabolic syndrome after three months of diet and physical activity.
hsCRP changes in the obese children with metabolic syndrome
Time frame: hsCRP levels were measured on day 1 of admittance and after three months 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 after three months of diet and physical activity.
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 19 Feb 2018.
- 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 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.
Mihai Gafencu, Md,PhD principal investigator
Louis Turcanu Emergency Hospital for Children
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Metabolically Benign, run by Louis Turcanu Emergency Hospital for Children.
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 19 Feb 2018. 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 NCT03435978, which also lists 2 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 19 Feb 2018.