Actively Recruiting
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD
Led by Vanderbilt University Medical Center · Updated on 2025-08-11
80
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Age 10 years or older
- Clinical diagnosis of Duchenne muscular dystrophy confirmed by muscle biopsy or genetic testing (for DMD cases)
- Informed consent from participants 18 years or older
- Parent/guardian consent and child assent for participants under 18 years
- BMI and race/ethnicity matched controls without DMD
- Controls must not have diabetes or evidence of impaired glucose tolerance, confirmed by normal or slightly elevated HbA1c and glucose tests when indicated
You will not qualify if you...
- Refusal to participate
- Diagnosis of diabetes or use of insulin/anti-diabetic drugs within 4 weeks prior to study
- Use of pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted devices
- Inability to comply with study procedures as judged by the investigator
- Controls diagnosed with Duchenne or Becker muscular dystrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
J
Jaclyn Tamaroff, MD
CONTACT
A
Andrea Lee, MA, MLS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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