Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents

Not Applicable

• Conditions: Childhood Obesity; Adolescent Obesity
• Interventions: Behavioral: Exercise

• Registration Number: NCT03762629
• Lead Sponsor: Guangzhou Sport University

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-02
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-04
• Last Update Posted: 2018-12-04
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Participants aged 7-17 years
2. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese intervention group	Exercise	Obese children were received exercise and diet intervention for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change from flow-mediated dilation (FMD) at 6 weeks	before and after the 6-week intervention	for brachial endothelial function assessment

Secondary Outcome Measures

Name	Time	Method
Change from pulse wave velocity at 6 weeks	before and after the 6-week intervention	for arterial stiffness assessment
Change from heart rate variability at 6 weeks	before and after the 6-week intervention	for cardiac autonomic function assessment
Change from circulating exosome-derived miRNAs at 6 weeks	before and after the 6-week intervention	exosome-secreted miRNA levels in plasma
Change from circulating irisin levels at 6 weeks	before and after the 6-week intervention	irisin concentration in plasma

Trial Locations

Locations (1)

Guangzhou Sport University; 🇨🇳 Guangzhou, Guangdong, China