Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy
Vanderbilt University Medical Center
Summary
Duchenne Muscular Dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD related CM. Despite risk factors for hyperglycemia, including the use of glucocorticoids, low muscle mass, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. In this Aim of the study, the investigators will assess the utility of remote wearable technology to predict changes in traditional metrics of metabolism and cardiac function. In this pilot study, 10 individuals with DMD will undergo cardiac magnetic resonance imaging (CMR) and oral glucose tolerance tests (OGTTs) at baseline and two years. The investigators will remotely assess glycemia (using continuous glucose monitors), HRV (using extended Holter monitors), and activity (using accelerometers) every 6 months over the 2 years and evaluate if changes in wearable metrics predict changes in CMR and OGTT.
Description
Risk for hyperglycemia and insulin resistance in DMD: Individuals with DMD have multiple risk factors for abnormal glucose and insulin metabolism: frequent use of glucocorticoid (GC) medication, decreased ambulation/activity, sarcopenia, and obesity. GC use is known to increase the risk of impaired glucose tolerance (IGT) and insulin resistance (IR) in multiple populations. Decreased skeletal muscle mass and function are associated with impaired skeletal muscle insulin sensitivity and type 2 diabetes (T2D). Despite these risks, there are limited data relating glycemia and IR in this population…
Eligibility
- Age range
- 10+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion and Exclusion Criteria: Inclusion criteria * Male- ≥10 years * Clinical phenotype of DMD confirmed with muscle biopsy or genotype. * Informed consent for individuals ≥18 years * Parent/guardian informed consent and child assent for individuals \< 18 years * Able to undergo non-sedated CMR Exclusion Criteria * Refusal to participate * Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in \< 4 weeks prior to treatment * Inability to fast for 10 hours * Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or other implante…
Interventions
- Devicewearable technology
Three wearable devices
Location
- Vanderbilt University Medical CenterNashville, Tennessee