RecruitingNCT06124196

Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

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


Sponsor

Vanderbilt University Medical Center

Enrollment

80 participants

Start Date

Mar 20, 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-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.


Eligibility

Sex: MALEMin Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study uses wearable glucose monitors and heart rate sensors to track blood sugar levels and heart rate variability in boys and young men with Duchenne muscular dystrophy (DMD), a genetic muscle-weakening disease, comparing them to matched healthy boys. The goal is to understand how DMD affects metabolism and heart function. **You may be eligible if...** - You are male and 10 years old or older - You have a confirmed diagnosis of Duchenne muscular dystrophy (DMD), OR - You are a healthy male matched for age and body type to a DMD participant (for the control group) **You may NOT be eligible if...** - You have been diagnosed with diabetes before joining the study, or are taking insulin or diabetes medications within the past 4 weeks - You have a pacemaker, implanted heart device, or other implanted electronic device - You are unwilling or unable to follow study procedures - You have Becker muscular dystrophy (for the control group) 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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NCT06124196


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