ObesityEDOCNCT01461226
Endothelial Dysfunction in Obese Children
A study testing Exercise training in people with Obesity and Atherosclerosis, run by University Hospital, Antwerp at 3 sites in Belgium.
Trial summary
The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Atherosclerosis
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesBelgium
- Study dates
- Jun 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
- Older than 16 yrs: BMI ≥35 kg/m²
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Zeepreventorium
De Haan, 8420
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
Edegem, 2650
Dienst Pediatrie, Universitair Ziekenhuis Antwerpen
Edegem, 2650
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Atherosclerosis
- Being tested
- Exercise training, Usual care
- Keywords
- overweight, cardiovascular risk factors, exercise training, endothelial function, endothelium, endothelial progenitor cells
- Medical subject headings
- Obesity, Atherosclerosis, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
Usual careBehavioural
Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance Receives: Behavioral: Exercise training |
| Usual Care | Other | Nutritional assessment and dietary advice by general practitioner, promotion of sports activities Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - 5 months - 10 months
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline - 5 months - 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Zeepreventorium
- Responsible party
- Principal investigator, Luc Bruyndonckx, University Hospital, Antwerp
- Investigators
- Viviane M Conraads, M.D., PhD, Principal investigator, Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461226
- Sponsor's protocol ID
- EC 11/11/100
- Acronym
- EDOC
- Status last verified
- Jul 2022
- First submitted
- 24 Oct 2011
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Obesity: What Determines Vascular Endothelial Dysfunction And Is The Process Reversible?
- ClinicalTrials.gov ID
- NCT01461226
- Acronym / sponsor ID
- EDOC / EC 11/11/100
- Conditions
- Obesity, Atherosclerosis
- Keywords
- overweight, cardiovascular risk factors, exercise training, endothelial function, endothelium, endothelial progenitor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Zeepreventorium
- Study start
- Jun 2011 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 15 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise trainingIndividualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance |
| Usual Care | Other | Behavioral: Usual careNutritional assessment and dietary advice by general practitioner, promotion of sports activities |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
- Older than 16 yrs: BMI ≥35 kg/m²
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingIndividualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance | Behavioural | Exercise training |
| Usual careNutritional assessment and dietary advice by general practitioner, promotion of sports activities | Behavioural | Usual Care |
Primary outcome
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months
Time frame: Baseline - 5 months - 10 months
Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function
2 secondary outcomes
Change From Baseline in Exercise Capacity at 5 and 10 Months
Time frame: Baseline - 5 months - 10 months
Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months
Time frame: Baseline - 5 months - 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viviane M Conraads, M.D., PhD principal investigator
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Obesity and Atherosclerosis, run by University Hospital, Antwerp at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months (time frame: Baseline - 5 months - 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.