Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment
Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment
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.
Inclusion Criteria:
Exclusion Criteria: