Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
The Children's Obesity Clinic, Department of Paediatrics, Copenhagen University Hospital Holbæk, Holbaek, Denmark.
BMJ Open. 2024 Nov 17;14(11):e082446. doi: 10.1136/bmjopen-2023-082446.
Childhood-onset obesity poses significant health risks, including early-onset type 2 diabetes, cardiovascular disease, and reduced quality of life. Hospital-based non-pharmacological obesity care can reduce childhood obesity, but 25% of children do not respond. Therefore, this study investigates the effect of the glucagon-like peptide-1 receptor agonist, semaglutide, as an add-on to hospital-based obesity care in youth who still have obesity following hospital-based obesity care as children. Furthermore, biomedical and psychosocial factors linked to treatment response will be investigated, alongside an exercise-based strategy to prevent weight regain and maintain a healthy body composition after semaglutide treatment.
This is an investigator-initiated, randomised, placebo-controlled, double-blind trial. We will enrol expectedly 180-270 young adults aged 18-28 years based on their previous response to a paediatric obesity management programme and their current body mass index (BMI). Participants are categorised into four groups: low treatment response (BMI SD score (SDS) reduction <0.10; BMI ≥30 kg/m); medium treatment response (BMI SDS reduction >0.25; BMI ≥30 kg/m); high treatment response (BMI SDS reduction >0.50; BMI <30 kg/m) and a population-based reference group with normal weight development in childhood. Participants with BMI ≥30 kg/m are randomised 2:1 to subcutaneous injections of semaglutide 2.4 mg/week or placebo as an add-on to hospital-based obesity care for 68 weeks. The primary outcome is the change in BMI from randomisation to the end of treatment with semaglutide compared with placebo. Secondary endpoints are changes in weight and body composition.
The trial has been approved by the Danish Medicines Agency and the Ethical Committee of the Capital Region of Denmark (H-20039422). The trial will be conducted in accordance with the Declaration of Helsinki and follow the guidelines for Good Clinical Practice. Results will be presented at international scientific conferences and published in peer-reviewed scientific journals.
EudraCT 2019-002274-31.
儿童期肥胖会带来严重的健康风险，包括早发 2 型糖尿病、心血管疾病和生活质量降低。基于医院的非药物性肥胖治疗可以降低儿童肥胖率，但仍有 25%的儿童对此没有反应。因此，本研究调查了胰高血糖素样肽-1 受体激动剂司美格鲁肽作为儿童期基于医院的肥胖治疗后仍存在肥胖的青少年肥胖治疗的附加治疗的效果。此外，还将研究与治疗反应相关的生物医学和社会心理因素，以及基于运动的策略，以防止体重反弹并在司美格鲁肽治疗后维持健康的身体成分。
这是一项由研究者发起的、随机、安慰剂对照、双盲试验。我们将根据他们以前对小儿肥胖管理计划的反应以及当前的体重指数（BMI），招募 180-270 名年龄在 18-28 岁的年轻成年人。参与者分为四组：低治疗反应组（BMI 标准差评分（SDS）降低<0.10；BMI≥30kg/m）；中治疗反应组（BMI SDS 降低>0.25；BMI≥30kg/m）；高治疗反应组（BMI SDS 降低>0.50；BMI<30kg/m）和儿童期体重正常发育的人群参考组。BMI≥30kg/m 的参与者以 2:1 的比例随机接受每周皮下注射司美格鲁肽 2.4mg 或安慰剂，作为基于医院的肥胖治疗的附加治疗，持续 68 周。主要结局是与安慰剂相比，随机分组至司美格鲁肽治疗结束时 BMI 的变化。次要结局是体重和身体成分的变化。
该试验已获得丹麦药品管理局和丹麦首都地区伦理委员会的批准（H-20039422）。该试验将按照赫尔辛基宣言和良好临床实践指南进行。结果将在国际科学会议上公布，并发表在同行评议的科学期刊上。
EudraCT 2019-002274-31。
