Frequency of Hypoglycemia in Children With Beta-blocker Treated Long QT-syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time spent in low glucose (<3.9 mmol/l)
研究概览
简要总结
The goal of this observational study is to investigate the frequency and characteristics of hypoglycemic episodes in children with long QT syndrome (LQTS) and beta-blocker treatment, specifically those receiving propranolol, compared to healthy controls. The study focuses on children under seven years with genetically confirmed LQTS and beta-blocker therapy, as well as healthy siblings as controls.
The main questions it aims to answer are:
- Does hypoglycemic episodes occur in children with LQTS who are treated with propranolol?
- Are there asymptomatic episodes of low blood glucose that could affect well-being and neurological development?
- Are there individual differences in susceptibility to hypoglycemia, and do genetic factors explain these differences?
- What is the incidence of hypoglycemia leading to emergency visits or hospitalizations among LQTS patients compared to healthy controls?
Researchers will compare children with LQTS on propranolol to healthy siblings to see if the frequency and severity of hypoglycemia differs between groups.
Participants will:
Have a Dexcom G7 continuous glucose monitor installed to record glucose profiles for ten days, both during an healthy episode and during an infection (when risk for hypoglycemia is increased).
If differences in susceptibility to hypoglycemia are observed, genetic data from the Helsinki biopank will be analyzed to explore potential genetic factors underlying these differences. Visits to emergency clinic and hospitalizations due to hypoglycemia will be retrospectively reviewed for all LQTS patients under 16 years old and compared to healthy controls.
Additional Details:
The study is conducted at Helsinki University Hospital (HUH) Children and Adolescents and the New Children's Hospital clinical research unit. The study aims to recruit 20-40 LQTS patients and 10 healthy controls.
The study is ethically justified, with no extra laboratory tests or costs for participants, and written consent will be obtained from parents and capable children.
The results are expected to improve the safety of propranolol treatment in LQTS children by identifying risk factors for hypoglycemia and informing preventive strategies, such as dietary guidance, use of glucose monitoring devices during illness, or considering selective beta-blockers for high-risk patients.
详细描述
Frequency of Hypoglycemia in Children with Beta-Blocker Treated Long QT Syndrome
What is Long QT Syndrome (LQTS)? Long QT syndrome is a rare, inherited heart condition that can cause sudden fainting episodes and increases the risk of heart arrhythmias and sudden death. It is caused by genetic changes affecting the heart's ion channels, which control electrical activity. In Finland, about 1 in 2,000 people have LQTS.
Why Beta-Blockers? Children diagnosed with LQTS are put on beta-blocker medication (usually propranolol) as infants to prevent life-threatening arrhythmias. Beta-blockers are effective but can increase the risk of low blood sugar (hypoglycemia), especially in young children.
Why Study Hypoglycemia? Hypoglycemia is a rare but potentially serious side effect of beta-blockers. Studies show that about 3% of children with LQTS on beta-blockers experience symptomatic hypoglycemia over five years, with the highest risk in young children. The most common symptom is a hypoglycemia-triggered seizure. It is not known how often mild or symptom-free low blood sugar occurs, which could affect a child's well-being and development if repeated.
Study Goals
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study group: children under 7 years of age with genetically confirmed LQTS (types 1 or 2) and on beta-blocker medication
- •Control group: healthy children (siblings of LQTS patients)
排除标准
- •Children with diabetes, inherited diseases of inborn error of metabolism, tube feeding, gastrointestinal operations with risk for dumping, medications leading to hypoglycemia, dialysis, or any severe acute illness
结局指标
主要结局
Time spent in low glucose (<3.9 mmol/l)
时间窗: 10 days continuous glucose monitoring
Time spent in low glucose (\<3.9 mmol/l) in GCM will be compared within the LQT patient group (during healthy episode vs during an infection)
次要结局
- Difference in time spent in very low glucose (<3.1 mmol/l)(10 days continuous glucose monitoring)
- Time spent in low glucose (<3.9 mmol/l) between groups(10 days continuous glucose monitoring)
- Nuber of finger prick confirmed hypoglycemic episodes(10 days continuous glucose monitoring)
- Number of participants with adverse outcomes at the device site(10 days continuous glucose monitoring)
研究者
Elina Hakonen
MD PhD Pediatrician
Helsinki University Central Hospital