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Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

Recruitingn/aAges 10 Years - anyMaleVanderbilt University Medical Center
NCT06124196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
CASE, DMD inclusion criteria: * Male * Age ≥10years * Clinical phenotype of DMD confirmed with muscle biopsy or genotype. * Informed consent for individuals ≥18 years * Parent/guardian informed consent and child assent for individuals \< 18 years CASE, DMD exclusion criteria: * Refusal to participate. * Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in \< 4 weeks prior to treatment * Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device * Unable to comply with study procedures, in the opinion of the investigator. CONTROL inclusion criteria: * Male * Age ≥10years * Informed consent for individuals ≥18 years * Parent/guardian informed consent and child assent for individuals \< 18 years * BMI matched by Centers for Disease Control and Prevention (CDC) category (underweight, normal, overweight, obese) to cases. * Self-reported race/ethnicity matched to cases. * No known evidence of diabetes, impaired fasting glucose, or impaired glucose tolerance: * For individuals (all ≥10 years) of age with obesity, we anticipate that they will have hemoglobin A1c (HbA1c) screening based on American Academy of Pediatrics (AAP) recommendations. * Participants will be included if they have a normal HbA1c (\< 5.7%) or if they have an elevated HbA1c (5.7-6.4%) with no evidence of impaired fasting glucose or impaired glucose tolerance on clinically obtained oral glucose tolerance tests (OGTT) (e.g., fasting glucose \<100mg/dL and 2-hour glucose \<140mg/dL). CONTROL, exclusion criteria: * Refusal to participate. * Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in \< 4 weeks prior to treatment * Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device * Unable to comply with study procedures, in the opinion of the investigator. * Diagnosis of DMD or Becker muscular dystrophy
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What it tests

  • wearable technology
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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