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临床试验/NCT04222101
NCT04222101终止不适用

Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy

Le Bonheur Children's Hospital2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年10月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Mak, MD

Principal Investigator

Le Bonheur Children's Hospital

研究点 (2)

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