NCT04222101

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

December 19, 2019

Last Update Submit

December 6, 2021

Conditions

Cardiomyopathy, DilatedCardiomyopathy, HypertrophicInsulin Resistance

Keywords

pediatrics

Outcome Measures

Primary Outcomes (1)

  • Whole body insulin sensitivity index

    correlate whole body insulin sensitivity index with left ventricular ejection fraction

    baseline

Secondary Outcomes (1)

  • FGF21 level

    baseline

Study Arms (1)

cardiomyopathy

OTHER

only one arm, all participants undergo oral glucose tolerance testing and results are used to evaluate association with degree of cardiac dysfunction

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance testDIAGNOSTIC_TEST

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

cardiomyopathy

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (11)

  • Towbin JA, Lowe AM, Colan SD, Sleeper LA, Orav EJ, Clunie S, Messere J, Cox GF, Lurie PR, Hsu D, Canter C, Wilkinson JD, Lipshultz SE. Incidence, causes, and outcomes of dilated cardiomyopathy in children. JAMA. 2006 Oct 18;296(15):1867-76. doi: 10.1001/jama.296.15.1867.

    PMID: 17047217BACKGROUND

  • Neglia D, De Caterina A, Marraccini P, Natali A, Ciardetti M, Vecoli C, Gastaldelli A, Ciociaro D, Pellegrini P, Testa R, Menichetti L, L'Abbate A, Stanley WC, Recchia FA. Impaired myocardial metabolic reserve and substrate selection flexibility during stress in patients with idiopathic dilated cardiomyopathy. Am J Physiol Heart Circ Physiol. 2007 Dec;293(6):H3270-8. doi: 10.1152/ajpheart.00887.2007. Epub 2007 Oct 5.

    PMID: 17921325BACKGROUND

  • Riehle C, Abel ED. Insulin Signaling and Heart Failure. Circ Res. 2016 Apr 1;118(7):1151-69. doi: 10.1161/CIRCRESAHA.116.306206.

    PMID: 27034277BACKGROUND

  • Fisher FM, Maratos-Flier E. Understanding the Physiology of FGF21. Annu Rev Physiol. 2016;78:223-41. doi: 10.1146/annurev-physiol-021115-105339. Epub 2015 Nov 19.

    PMID: 26654352BACKGROUND

  • Camporez JP, Jornayvaz FR, Petersen MC, Pesta D, Guigni BA, Serr J, Zhang D, Kahn M, Samuel VT, Jurczak MJ, Shulman GI. Cellular mechanisms by which FGF21 improves insulin sensitivity in male mice. Endocrinology. 2013 Sep;154(9):3099-109. doi: 10.1210/en.2013-1191. Epub 2013 Jun 13.

    PMID: 23766126BACKGROUND

  • Shah A, Shannon RP. Insulin resistance in dilated cardiomyopathy. Rev Cardiovasc Med. 2003;4 Suppl 6:S50-7.

    PMID: 14668703RESULT

  • Davila-Roman VG, Vedala G, Herrero P, de las Fuentes L, Rogers JG, Kelly DP, Gropler RJ. Altered myocardial fatty acid and glucose metabolism in idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2002 Jul 17;40(2):271-7. doi: 10.1016/s0735-1097(02)01967-8.

    PMID: 12106931RESULT

  • Nikolaidis LA, Sturzu A, Stolarski C, Elahi D, Shen YT, Shannon RP. The development of myocardial insulin resistance in conscious dogs with advanced dilated cardiomyopathy. Cardiovasc Res. 2004 Feb 1;61(2):297-306. doi: 10.1016/j.cardiores.2003.11.027.

    PMID: 14736546RESULT

  • Swan JW, Anker SD, Walton C, Godsland IF, Clark AL, Leyva F, Stevenson JC, Coats AJ. Insulin resistance in chronic heart failure: relation to severity and etiology of heart failure. J Am Coll Cardiol. 1997 Aug;30(2):527-32. doi: 10.1016/s0735-1097(97)00185-x.

    PMID: 9247528RESULT

  • Witteles RM, Tang WH, Jamali AH, Chu JW, Reaven GM, Fowler MB. Insulin resistance in idiopathic dilated cardiomyopathy: a possible etiologic link. J Am Coll Cardiol. 2004 Jul 7;44(1):78-81. doi: 10.1016/j.jacc.2004.03.037.

    PMID: 15234411RESULT

  • Sakai Y, Maruyama T, Katsuta H, Kogawa K, Akashi T, Izumi K, Tominaga H, Kono S, Nagafuchi S, Harada M. Patients with dilated cardiomyopathy possess insulin resistance independently of cardiac dysfunction or serum tumor necrosis factor-alpha. Int Heart J. 2006 Nov;47(6):877-87. doi: 10.1536/ihj.47.877.

    PMID: 17268122RESULT

MeSH Terms

Conditions

Cardiomyopathy, DilatedCardiomyopathy, HypertrophicInsulin Resistance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Daniel Mak, MD

    Le Bonheur/UTHSC Pediatric Endocrine fellowship

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 9, 2020

Study Start

October 7, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

This is a single center, pilot study; data will not be made available but findings from the study will be published

Locations

US(1)