Effect of Diet and Physical Activity on Adipokines

February 15, 2018 updated by: Ramona Stroescu, Louis Turcanu Emergency Hospital for Children

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All children admitted to the Endocrinology, Diabetology and Cardiology Department who met the Inclusion Criteria

Description

Inclusion Criteria:

  • obese children (BMI> 95th percentile)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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-
Data processing from Patient Medical Files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Turcanu Emergency Hospital for Children

Collaborators

University of Medicine and Pharmacy "Victor Babes" Timisoara

Investigators

  • Principal Investigator: Mihai Gafencu, Md,PhD, Louis Turcanu Emergency Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

January 3, 2018

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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