Endothelial Dysfunction in Obese Children (EDOC)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Atherosclerosis
• Intervention / Treatment: Behavioral: Exercise training; Behavioral: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viviane M Conraads, M.D., PhD; Phone Number: 0032 38215672; Email: viviane.conraads@uza.be
• Study Contact Backup: Name: Luc Bruyndonckx, M.D.; Phone Number: 0032 38215222; Email: luc.bruyndonckx@uza.be

Study Locations

• Belgium
  • De Haan, Belgium, 8420
    • Zeepreventorium
  • Edegem, Belgium, 2650
    • Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
  • Edegem, Belgium, 2650
    • Dienst Pediatrie, Universitair Ziekenhuis Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training; Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Behavioral: Exercise training; Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
Other: Usual Care; Nutritional assessment and dietary advice by general practitioner, promotion of sports activities	Behavioral: Usual care; Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Zeepreventorium
• Investigators: Principal Investigator: Viviane M Conraads, M.D., PhD, Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: overweight; exercise training; cardiovascular risk factors; endothelial function; endothelium; endothelial progenitor cells
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Atherosclerosis
• Other Study ID Numbers: EC 11/11/100