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Completed

NCT Number: NCT03435978

Effect of Diet and Physical Activity on Adipokines

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).

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Key information

Conditions

Obesity, Metabolically Benign Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese children (BMI> 95th percentile)

Exclusion criteria

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

Treatment and study plan

MetS+

Behavioral

MetS-

Other

Data processing from Patient Medical Files

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Louis Turcanu Emergency Hospital for Children

Other

Collaborators

  • University of Medicine and Pharmacy "Victor Babes" Timisoara

Registry information

Official study title

Effect of Three-month Diet and Physical Activity on Adipokines and Inflammatory Status in Children With Metabolic Syndrome

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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