Effect of Diet and Physical Activity on Adipokines

Obesity, Metabolically Benign Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435978
• Other study ID #: 13200
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 15, 2018
• Start date: January 1, 2016
• Est. completion date: January 3, 2018

Study information

• Verified date: February 2018
• Source: Louis Turcanu Emergency Hospital for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 3, 2018
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• obese children (BMI> 95th percentile)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Obesity, Metabolically Benign

Intervention

Behavioral:
• MetS+

Other:
• MetS-
Data processing from Patient Medical Files

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Louis Turcanu Emergency Hospital for Children	University of Medicine and Pharmacy "Victor Babes" Timisoara

References & Publications (2)

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. 2017 Jan 1:4563217733286. doi: 10.1177/0004563217733286. [Epub ahead of print] — View Citation

Beyazit F, Ünsal 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weight and height were measured on day 1 of admission. Obesity was defined as a BMI > the 95th percentile.
Primary	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.	Leptin levels were measured on day 1 of admission and after three months. Normal range was considered < 24ng/ml.
Primary	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.	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.
Primary	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.	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.