Clinical trial NCT03435978: Effect of Diet and Physical Activity on Adipokines
Official title: Effect of Three-month Diet and Physical Activity on Adipokines and Inflammatory Status in Children With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Metabolically Benign
Keywords: diet
metabolic syndrome
obese children
Lead sponsor: Louis Turcanu Emergency Hospital for Children
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy "Victor Babes" Timisoara
First posted: 2018-02-19
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* obese children (BMI\> 95th percentile)

Exclusion Criteria:

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

Primary outcomes:
measure: Defining obesity in the pediatric population
timeFrame: Weight and height were measured on day 1 of admission. Obesity was defined as a BMI > the 95th percentile.
measure: Leptin changes in the obese children with metabolic syndrome
timeFrame: Leptin levels were measured on day 1 of admission and after three months. Normal range was considered < 24ng/ml.
measure: Adiponectin changes in the obese children with metabolic syndrome
timeFrame: 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.
measure: hsCRP changes in the obese children with metabolic syndrome
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Louis Turcanu Emergency Hospital for Children
name: Mihai Gafencu, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.