Atherosclerosis, Obesity
Conditions
Keywords
overweight, cardiovascular risk factors, exercise training, endothelial function, endothelium, endothelial progenitor cells
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: 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.
Interventions
BEHAVIORALExercise training
Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
BEHAVIORALUsual care
Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Sponsors
Zeepreventorium
University Hospital, Antwerp
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | Baseline - 5 months - 10 months | Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Exercise Capacity at 5 and 10 Months | Baseline - 5 months - 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 | Baseline - 5 months - 10 months | Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Training Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance | 33 |
| Usual Care Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities | 28 |
| Total | 61 |
Baseline characteristics
| Characteristic | Usual Care | Total | Exercise Training |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 61 Participants | 33 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15 years STANDARD_DEVIATION 1.2 | 15 years STANDARD_DEVIATION 1.3 | 15 years STANDARD_DEVIATION 1.5 |
| BMI | 36.72 kg/m² STANDARD_DEVIATION 5.83 | 36.58 kg/m² STANDARD_DEVIATION 5.33 | 36.44 kg/m² STANDARD_DEVIATION 4.82 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 22 Participants | 46 Participants | 24 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 28 |
| other Total, other adverse events | 0 / 33 | 0 / 28 |
| serious Total, serious adverse events | 0 / 33 | 0 / 28 |
Outcome results
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
Time frame: Baseline - 5 months - 10 months
Population: this was an intention to treat analysis. Some participants ended the treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exercise Training | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | 10 months | 1.9 arbitrary units |
| Exercise Training | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | 5 months | 2.01 arbitrary units |
| Exercise Training | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | baseline | 1.48 arbitrary units |
| Usual Care | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | 10 months | 1.5 arbitrary units |
| Usual Care | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | 5 months | 1.55 arbitrary units |
| Usual Care | Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months | baseline | 1.42 arbitrary units |
Comparison: change after 10 months between groupsp-value: 0.04Mixed Models Analysis
p-value: <0.05Mixed Models Analysis
p-value: 0.64Mixed Models Analysis
p-value: 0.6Mixed Models Analysis
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
Time frame: Baseline - 5 months - 10 months
Population: this is an intention to treat analysis. Some participants ended treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise Training | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | baseline | 36.44 kg/m² | Standard Deviation 4.82 |
| Exercise Training | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | 5 months | 30.07 kg/m² | Standard Deviation 3.85 |
| Exercise Training | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | 10 months | 27.39 kg/m² | Standard Deviation 3.57 |
| Usual Care | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | baseline | 36.72 kg/m² | Standard Deviation 5.83 |
| Usual Care | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | 5 months | 38.40 kg/m² | Standard Deviation 5.62 |
| Usual Care | Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months | 10 months | 39.10 kg/m² | Standard Deviation 5.26 |
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
Time frame: Baseline - 5 months - 10 months
Population: this an intention to treat analysis. Some participants ended the treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exercise Training | Change From Baseline in Exercise Capacity at 5 and 10 Months | baseline | 150 watt |
| Exercise Training | Change From Baseline in Exercise Capacity at 5 and 10 Months | 5 months | 170 watt |
| Exercise Training | Change From Baseline in Exercise Capacity at 5 and 10 Months | 10 months | 170 watt |
| Usual Care | Change From Baseline in Exercise Capacity at 5 and 10 Months | baseline | 150 watt |
| Usual Care | Change From Baseline in Exercise Capacity at 5 and 10 Months | 5 months | 150 watt |
| Usual Care | Change From Baseline in Exercise Capacity at 5 and 10 Months | 10 months | 130 watt |