This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity. Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months. In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.
Childhood obesity is associated with early structural and functional cardiac alterations, including subclinical myocardial dysfunction. Conventional echocardiographic parameters may not detect early changes. This is a prospective, randomized, controlled, open-label clinical trial including children aged 6-12 years with severe obesity (BMI Z-score ≥ +3). Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone. Participants are followed for 6 months with clinical, laboratory, imaging, and functional assessments. In addition to the primary randomized comparison, a predefined longitudinal subgroup analysis is conducted in participants receiving liraglutide to assess cardiovascular effects using advanced echocardiographic techniques, including speckle-tracking analysis of left ventricular global longitudinal strain and left atrial reservoir strain. This study was registered retrospectively because participant enrollment began prior to trial registration due to administrative reasons. The study protocol and outcomes were defined prior to participant inclusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Liraglutide administered as a once-daily subcutaneous injection, starting at 0.6 mg and titrated weekly up to 3.0 mg or maximum tolerated dose, for 6 months, combined with lifestyle intervention.
Childrens Institute - University of Sao Paulo
São Paulo, São Paulo, Brazil
Change in Body Mass Index (BMI)
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). BMI will be assessed at baseline and after 6 months using standardized anthropometric measurements.
Time frame: 6 months
Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography
LV-GLS will be obtained by transthoracic echocardiography using two-dimensional speckle-tracking analysis according to current American Society of Echocardiography recommendations. Measurements will be expressed as percentage (%) and evaluated at baseline and after 6 months.
Time frame: 6 months
Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography
LASr will be obtained from apical four-chamber views using two-dimensional speckle-tracking echocardiography and expressed as percentage (%). Measurements will be performed at baseline and after 6 months according to current American Society of Echocardiography recommendations
Time frame: 6 months
Change in fasting plasma glucose
Fasting plasma glucose levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Time frame: Baseline to 6 months
Change in fasting insulin levels
Fasting insulin levels will be measured from venous blood samples and expressed in µIU/mL. Changes between baseline and 6 months will be evaluated
Time frame: 6 months
Change in triglyceride levels
Serum triglyceride levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Time frame: 6 months
Change in total cholesterol levels
Total cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Time frame: 6 months
Change in HDL cholesterol levels
HDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Time frame: 6 months
Change in LDL cholesterol levels
LDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Time frame: 6 months
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