Endothelial Dysfunction in Obese Children

NCT01461226 | Completed Results

• 1 other identifier: EC 11/11/100
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Obesity; Atherosclerosis

Keywords

overweight; cardiovascular risk factors; exercise training; endothelial function; endothelium; endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Exercise Capacity 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

  Baseline - 5 months - 10 months

Study Arms (2)

Exercise training

EXPERIMENTAL

Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance

Behavioral: Exercise training

Usual Care

OTHER

Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Behavioral: Usual care

Interventions

Exercise training BEHAVIORAL

Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance

Exercise training

Usual care BEHAVIORAL

Nutritional assessment and dietary advice by general practitioner, promotion of sports activities

Usual Care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
• Older than 16 yrs: BMI ≥35 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Zeepreventorium: collaborator

Study Sites (3)

Zeepreventorium

De Haan, 8420, Belgium

Location

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Dienst Pediatrie, Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Obesity; Atherosclerosis; Overweight

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: dr. Luc bruyndonckx
• Organization: University of Antwerp/Antwerp University Hospital

luc.bruyndonckx@uza.be

003238213000

Study Officials

• Viviane M Conraads, M.D., PhD

  Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 28, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 15, 2023
• Results First Posted: May 15, 2023

Record last verified: 2022-07

Locations

BE (3)