N/A
Completed N=61
Endothelial Dysfunction in Obese Children
Source: ClinicalTrials.gov NCT01461226 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months — 1.9; 1.5; 2.01; 1.55 arbitrary units — p=<0.05
Summary
The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months |
1.9; 1.5; 2.01; 1.55; 1.48; 1.42 | <0.05 sig |
| SECONDARY Change From Baseline in Exercise Capacity at 5 and 10 Months |
150; 150; 170; 150; 170; 130 | — |
| SECONDARY Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months |
36.44; 36.72; 30.07; 38.40; 27.39; 39.10 | — |
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
Data sourced from ClinicalTrials.gov (NCT01461226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.