Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years
- •BMI Z-score ≥ +3
- •Previous unsuccessful lifestyle intervention
排除标准
- •Severe chronic diseases
- •Cardiac disease
- •Dermatological contraindication
- •Use of interfering medications
研究组 & 干预措施
Liraglutide + Lifestyle Intervention
Participants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention.
Intervention:
Drug: Liraglutide Behavioral: Lifestyle intervention
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml (Drug)
Lifestyle Intervention Alone
Participants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: 6 months
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.
次要结局
- Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography(6 months)
- Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography(6 months)
- Change in fasting plasma glucose(Baseline to 6 months)
- Change in fasting insulin levels(6 months)
- Change in triglyceride levels(6 months)
- Change in total cholesterol levels(6 months)
- Change in HDL cholesterol levels(6 months)
- Change in LDL cholesterol levels(6 months)
研究者
Louise Cominato
MD, PhD
University of Sao Paulo General Hospital