Status:
RECRUITING
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
10+ years
Brief 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 kn...
Detailed Description
This study is a critical first step in evaluating hyperglycemia in DMD and the relationship to autonomic dysfunction. Our findings will help establish screening guidelines and provide a basis for inte...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06124196
Start Date
March 20 2024
End Date
February 1 2031
Last Update
August 11 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232