Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Whole body insulin sensitivity index
研究概览
简要总结
This study will investigate whether there is an association between insulin resistance and cardiac function in children with dilated or hypertrophic cardiomyopathy. This study will also investigate whether there is an association between FGF21 and cardiac function in children with dilated or hypertrophic cardiomyopathy and whether this is mediated through greater insulin resistance and/or through independent effects.
详细描述
Although pediatric cardiomyopathy is rare, the condition is severe and life-threatening. The main focus of this proposed study will examine whether insulin resistance is correlated with decreased cardiac function which will hopefully pave the way for future clinical trials using medications that sensitize insulin such as metformin or glucagon-like peptide-1 (GLP-1 agonists) as possible therapeutic agents. The exploratory piece of this study will investigate a novel therapeutic target by determining whether FGF21 has any direct effects on cardiac function and whether it interacts with insulin resistance in altering cardiac function. Patients with cardiomyopathy normally undergo ECHO as part of routine evaluation and follow up and is standard of care. At this time, there are no official guidelines for pediatric patients with cardiomyopathy to undergo oral glucose tolerance testing (OGTT) and thus it is not part of the standard of care. Based on findings from this study, the investigators hope to justify performing an OGTT on pediatric patients with dilated or hypertrophic cardiomyopathy and incorporate the procedure in future practice guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of dilated or hypertrophic cardiomyopathy
- •Pubertal (Tanner 2 breast in females or testicular volume ≥ 4mL in males)
- •Permission by the primary cardiologist of the patient for enrollment in the study
排除标准
- •Prior diagnosis of diabetes and treatment with anti-diabetes medication
- •Neuromuscular disorder
- •Inborn error of metabolism
- •Malformation syndrome
- •Clinically unstable based on the assessment of the primary cardiologist caring for the patient
- •inability of parent/legal guardian to provide informed consent
- •non-English speaking
结局指标
主要结局
Whole body insulin sensitivity index
时间窗: baseline
correlate whole body insulin sensitivity index with left ventricular ejection fraction
次要结局
- FGF21 level(baseline)
研究者
Daniel Mak, MD
Principal Investigator
Le Bonheur Children's Hospital
