Back to results

Endothelial Dysfunction in Obese Children (EDOC)

Primary Purpose

Obesity, Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Exercise training

Usual care

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight, cardiovascular risk factors, exercise training, endothelial function, endothelium, endothelial progenitor cells

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zeepreventorium
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
Dienst Pediatrie, Universitair Ziekenhuis Antwerpen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise training

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01461226

First Posted

October 24, 2011

Last Updated

July 7, 2022

Sponsor

University Hospital, Antwerp

Collaborators

Zeepreventorium

1. Study Identification

Unique Protocol Identification Number

NCT01461226

Brief Title

Endothelial Dysfunction in Obese Children

Acronym

EDOC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 2011 (Actual)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

Collaborators

Zeepreventorium

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Atherosclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise training

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Care

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months

Description

Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Time Frame

Baseline - 5 months - 10 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Exercise Capacity at 5 and 10 Months

Description

Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months

Time Frame

Baseline - 5 months - 10 months

Title

Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months

Description

Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months

Time Frame

Baseline - 5 months - 10 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Viviane M Conraads, M.D., PhD

Organizational Affiliation

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zeepreventorium

City

De Haan

ZIP/Postal Code

8420

Country

Belgium

Facility Name

Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Dienst Pediatrie, Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Endothelial Dysfunction in Obese Children

We'll reach out to this number within 24 hrs