Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06124196
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
10 Years - N/A
Healthy Volunteers
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-CM, now the leading cause of death in patients with DMD. Despite risk factors for hyperglycemia, including the use of glucocorticoids (GCs), sarcopenia, 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. The goal of this remote study is to evaluate rates of hyperglycemia in individuals with DMD compared to control participants using continuous glucose monitors, and to determine the relationship between hyperglycemia and heart rate variability. Participants will utilize continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep.

Key Dates

Start date
Mar 20, 2024
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Case - DMD
    40 male individuals with DMD
  • Arm: Controls
    40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).

Primary Outcome Measure

Rate of hyperglycemia [ Time Frame: once over 10 days ]

Central Contacts

Locations (1)

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