Topiramate and Severe Obesity in Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in Body Mass Index (BMI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.
详细描述
Childhood obesity remains through adulthood in main cases, and is associated with an early increase of cardiovascular risk and an excess mortality in young adults due to stroke and cancer.
Bariatric surgery is very rare in France for children and can cause severe complications. Long term effects are still unknown.
Topiramate is already use in thousands of children in neurology, its effects are already well known, and no lethal complication is reported.
The hypothesis is that Topiramate associated with standard treatment of obesity is more effective than standard treatment alone.
This will be a 4.5-years, randomized, double-blind, placebo-controlled, clinical trial of topiramate (9 months) vs placebo (9months) for Body Mass Index reduction in 160 adolescents (ages 9-17 years old) with severe obesity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •9-17 years old
- •Body Mass Index Z-score ≥ 4 SD of French reference
- •Weight at enrolment ≥ 50 kg
- •Therapeutic failure > 6 months
- •For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin)
- •Negative pregnancy test for girls of childbearing age
- •Agreeing to participate upon written informed consent
- •Appropriate understanding of the study
排除标准
- •Syndromic or secondary obesity
- •Major neurological or psychiatric disorder
- •Current or history of suicidal thought/attempts
- •Current or history of breakdown
- •Previous bariatric surgery
- •Severe hypercapnia
- •Renal dysfunction
- •Deformity in the urinary tract or solitary kidney
- •History of renal lithiasis or glaucoma
- •Poorly controlled diabetic children or adolescents (HbA1c >10%) and diabetic patients treated with Metformine and/or glibenclamide
- •Hepatic dysfunction
- •Bicarbonate ≤16 mmol/L
- •Known hypersensitivity to the active substance or to one of the excipients
- •Intolerance to saccharose
- •Enrolment in another therapeutic study
- •High probability to fail to comply with treatment
- •Females: Pregnant, planning to become pregnant
- •No signature on consent form
- •Uncovered by the French National health Insurance system (Sécurité sociale)
研究组 & 干预措施
topiramate
pill
干预措施: Topiramate (Drug)
placebo
Sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Mass Index (BMI)
时间窗: 9 months
Success is defined by a percent change \> 2.5%
次要结局
- Percent Change from Baseline in Body Mass Index Z-score(9 months)
- Adverse event outcome(Up to 4,5 years of follow-up)
- Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score(6 months)
- Eating Behaviour(9 months)
- Physical activity(9 months)
- Food intake(9 months)
- Comorbidity outcome(9 months)