Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06093100
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • wearable technology — DEVICE
    Three wearable devices

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
10 participants (estimated)

Primary Outcome Measure

Rate of hyperglycemia [ Time Frame: 5 time points, each over 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Jaclyn Tamaroff, MD
[email protected]
615-875-7853
Andrea Lee
[email protected]
615-875-9602

Find similar trials in Nashville, TN

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
Vanderbilt University Medical Center· Nashville, TN

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