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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222101
Enrollment
9
Registered
2020-01-09
Start date
2019-10-07
Completion date
2021-06-30
Last updated
2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Insulin Resistance

Keywords

pediatrics

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTOral glucose tolerance test

measure insulin, glucose and FGF21 levels in response to oral glucose challenge

Sponsors

Le Bonheur Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Whole body insulin sensitivity indexbaselinecorrelate whole body insulin sensitivity index with left ventricular ejection fraction

Secondary

MeasureTime frameDescription
FGF21 levelbaselinecorrelate FGF21 levels with whole body sensitivity index and left ventricular ejection fraction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026