RecruitingNCT06093100

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

Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy


Sponsor

Vanderbilt University Medical Center

Enrollment

10 participants

Start Date

Jul 10, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study uses wearable devices to track blood sugar levels and heart rate patterns in boys and young men with Duchenne muscular dystrophy (DMD) — a progressive muscle disease. The goal is to understand how their bodies manage blood sugar over time, since DMD can affect the heart and metabolism in ways that sometimes go undetected. **You may be eligible if...** - You are male and at least 10 years old - You have a confirmed diagnosis of Duchenne muscular dystrophy (by biopsy or genetic testing) - You are able to undergo a cardiac MRI without sedation - A parent or guardian can provide consent if you are under 18 **You may NOT be eligible if...** - You already have a diabetes diagnosis or are taking insulin or diabetes medication - You are unable to fast for 10 hours - You have a pacemaker or other implanted heart device - You are unable to follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEwearable technology

Three wearable devices


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06093100


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