ClinicalTrials.gg
CompletedNCT03435978Updated Feb 19, 2018

Effect of Diet and Physical Activity on Adipokines

An observational study in Obesity, Metabolically Benign, sponsored by Louis Turcanu Emergency Hospital for Children. Completed. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Louis Turcanu Emergency Hospital for Children · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
5 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity, Metabolically Benign

Keywords

  • diet
  • metabolic syndrome
  • obese children
03

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 66 is below 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 Louis Turcanu Emergency Hospital for Children as lead sponsor.

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

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • MetS+

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

    Behavioral: MetS+

  • MetS-

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

    Other: MetS-

Interventions

  • BehavioralMetS+
  • OtherMetS-

    Data processing from Patient Medical Files

06

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 after three months of diet and physical activity.

    Time frame: Leptin levels were measured on day 1 of admission and after three months. 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 after three months of diet and physical activity.

    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.

  4. 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.

    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.

07

Study locations

No study locations are listed for this record.

08

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 ↗
  • 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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Dec 2016, 11 months.

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

Registered
Jan 31, 2018
First posted
Feb 19, 2018
StartActual
Jan 1, 2016
Primary completionActual
Dec 31, 2016
CompletionActual
Jan 3, 2018
Last update
Feb 19, 2018
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 Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03435978
Lead sponsor
Louis Turcanu Emergency Hospital for Children
Collaborators
University of Medicine and Pharmacy "Victor Babes" Timisoara
Responsible party
Ramona Stroescu (MD,PhD,Clinical Researcher, Louis Turcanu Emergency Hospital for Children) — Principal investigator
First posted
Feb 19, 2018
Start date
Jan 1, 2016
Primary completion
Dec 31, 2016
Completion
Jan 3, 2018
Last update
Feb 19, 2018

Study contacts

Mihai Gafencu, Md,PhD
principal investigator · Louis Turcanu Emergency Hospital for Children

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 Feb 2018. You cannot join it, but the record below documents what was studied.

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