Effect of Diet and Physical Activity on Adipokines

NCT03435978 | Completed DMC

• 1 other identifier: 13200
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obesity, Metabolically Benign

Keywords

diet; metabolic syndrome; obese children

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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

MetS- OTHER

Data processing from Patient Medical Files

MetS-

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• obese children (BMI\> 95th percentile)

You may not qualify if:

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

Sponsors & Collaborators

• Louis Turcanu Emergency Hospital for Children: lead
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator

Related Publications (2)

• 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.

  PMID: 28890432 BACKGROUND

• 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.

  PMID: 28882065 BACKGROUND

MeSH Terms

Conditions

Obesity, Metabolically Benign; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Mihai Gafencu, Md,PhD

  Louis Turcanu Emergency Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Clinical Researcher

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: January 3, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share