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Clinical Trials/NCT03762629
NCT03762629
Unknown
N/A

Effects of Exercise Training and Diet Restriction on Cardiovascular Function and Their Related Factors in Obese Chinese Children and Adolescents: an Intervention Study

Guangzhou Sport University1 site in 1 country90 target enrollmentJuly 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Guangzhou Sport University
Enrollment
90
Locations
1
Primary Endpoint
Change from flow-mediated dilation (FMD) at 6 weeks
Last Updated
7 years ago

Overview

Brief Summary

Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may already be associated with serious comorbidities, obese adolescents are at significantly higher risk for obesity and increased morbidity and mortality during adulthood. Combined lifestyle interventions, which include regular physical activity and dietary restriction, have been shown to result in most significant improvements in cardiovascular function and their associated factors in the pediatric and adolescent population with obesity. The aim of this study is to investigate the effects of a combined exercise and diet intervention on cardiovascular function and their associated factors in obese children.

Detailed Description

Sixty obese children and adolescents will complete a 6-week program of exercise and diet intervention. Thirty normal-weight children and adolescents will be recruited as control group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin levels of the subjects will be measured before and after 6-week intervention. Endothelial function will be assessed by a flow-mediated dilation test. Circulating exosome-derived miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin concentration in plasma and arterial stiffness as well as cardiac autonomic function will be investigated before and after the 6-week intervention. Fecal samples were collected before and after the 6-week intervention for analysis of the compositional and functional changes in the human gut microbiota.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Sport University
Responsible Party
Principal Investigator
Principal Investigator

Min Hu

Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion

Guangzhou Sport University

Eligibility Criteria

Inclusion Criteria

  • Participants aged 7-17 years
  • Participants satisfied the obesity diagnosis criteria is based on "Body mass index reference standards for the screening of overweight and obesity in Chinese children and adolescents" released in 2004, with cut-off points of p(95) for obesity

Exclusion Criteria

  • Metabolic disease
  • Gastrointestinal disease
  • Cardiac disease
  • Taking medications which affected energy expenditure
  • Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal

Outcomes

Primary Outcomes

Change from flow-mediated dilation (FMD) at 6 weeks

Time Frame: before and after the 6-week intervention

for brachial endothelial function assessment

Secondary Outcomes

  • Change from pulse wave velocity at 6 weeks(before and after the 6-week intervention)
  • Change from heart rate variability at 6 weeks(before and after the 6-week intervention)
  • Change from circulating exosome-derived miRNAs at 6 weeks(before and after the 6-week intervention)
  • Change from circulating irisin levels at 6 weeks(before and after the 6-week intervention)

Study Sites (1)

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