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Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity
Sponsor: University of Sao Paulo General Hospital
Summary
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.
Official title: Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-30
Completion Date
2028-04
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
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.
Locations (1)
Childrens Institute - University of Sao Paulo
São Paulo, São Paulo, Brazil