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Cardiomyopathy, DilatedNCT04222101

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

A study testing Oral glucose tolerance test in people with Cardiomyopathy, Dilated and Cardiomyopathy, Hypertrophic, run by Le Bonheur Children's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
What is being tested?
Oral glucose tolerance test
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
7 Oct 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

Other trials in United States

About this study

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.

Read the 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.

Being tested
Oral glucose tolerance test
Keywords
pediatrics
Medical subject headings
Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral glucose tolerance testDiagnostic test

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

Study groups in NCT04222101
Study groupRoleWhat they receive
cardiomyopathyOtheronly one arm, all participants undergo oral glucose tolerance testing and results are used to evaluate association with degree of cardiac dysfunction
Receives: Diagnostic Test: Oral glucose tolerance test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole body insulin sensitivity index

    correlate whole body insulin sensitivity index with left ventricular ejection fraction

    Measured: baseline

Secondary outcomes (1)

  1. FGF21 level

    correlate FGF21 levels with whole body sensitivity index and left ventricular ejection fraction

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study start7 Oct 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Why it stopped: COVID-19 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04222101
Sponsor's protocol ID
19-06748-FB
Status last verified
Dec 2021
First submitted
19 Dec 2019
Last updated
20 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a single center, pilot study; data will not be made available but findings from the study will be published

Publications

  • 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.

    PubMed 17047217

  • 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.

    PubMed 17921325

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

    PubMed 27034277

  • 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.

    PubMed 26654352

  • 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.

    PubMed 23766126

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

    PubMed 14668703

  • 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.

    PubMed 12106931

  • 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.

    PubMed 14736546

  • 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.

    PubMed 9247528

  • 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.

    PubMed 15234411

  • 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.

    PubMed 17268122

Questions about this trial

What is this clinical trial studying?

A study testing Oral glucose tolerance test in people with Cardiomyopathy, Dilated and Cardiomyopathy, Hypertrophic, run by Le Bonheur Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole body insulin sensitivity index (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04222101, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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