Endothelial Dysfunction in Obese Children

Obesity Clinical Trial

— EDOC  

Official title:

Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461226
• Other study ID #: EC 11/11/100
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: July 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.

Description:

The favorable responses of combined treatment strategies, consisting of exercise training and proper diet change, for childhood and adolescent obesity on vascular health are poorly understood. The overall objective of this research project is to investigate the underlying pathophysiological mechanisms that mediate these beneficial effects.

Particularly, the following aims are set forth:

1. To establish the effect of a combined lifestyle intervention, i.e. an individualized exercise training and caloric restriction program, on vascular function (primary endpoint) and structure in a substantial population of obese adolescents.

2. To characterize causal pathways between obesity and endothelial dysfunction with focus on classical risk factors, oxidative and inflammatory stress, metabolic adaptations, bone marrow derived progenitor cells, and blood microparticles.

This research knowledge will be instrumental for risk stratification and clinical management aimed to improve endothelial function by limiting damage and reinforcing regenerative mechanisms in obese adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria: Children with severe obesity

• Younger than 16 yrs: BMI =97th sex and age specific BMI-percentile

• Older than 16 yrs: BMI =35 kg/m²

Exclusion Criteria:

• Acute or chronic inflammatory process, use of non-steroidal anti- inflammatory drugs or immunosuppressive drugs. (including inhalation corticosteroids).

• Structural heart disease or other cardiac diseases.

• Active malignant hematological disease

Related Conditions & MeSH terms

• Atherosclerosis
• Obesity

Intervention

Behavioral:
• Exercise training
Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
• Usual care
Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Locations

Country	Name	City	State
Belgium	Zeepreventorium	De Haan
Belgium	Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Dienst Pediatrie, Universitair Ziekenhuis Antwerpen	Edegem

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Zeepreventorium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months	Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function	Baseline - 5 months - 10 months
Secondary	Change From Baseline in Exercise Capacity at 5 and 10 Months	Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months	Baseline - 5 months - 10 months
Secondary	Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months	Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months	Baseline - 5 months - 10 months