Actively Recruiting

Age: 10Years +
MALE
Healthy Volunteers
NCT06124196

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

Age: 10Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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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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