Status:
RECRUITING
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim
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
Risk for hyperglycemia and insulin resistance in DMD: Individuals with DMD have multiple risk factors for abnormal glucose and insulin metabolism: frequent use of glucocorticoid (GC) medication, decre...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria:
- Inclusion criteria
- Male- ≥10 years
- 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
- Able to undergo non-sedated CMR
- 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
- Inability to fast for 10 hours
- Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted device
- Unable to comply with study procedures, in the opinion of the investigator.
Exclusion
Key Trial Info
Start Date :
July 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06093100
Start Date
July 10 2024
End Date
December 1 2030
Last Update
November 6 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232