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Controls for Duchenne Muscular Dystrophy

N/A
Recruiting
Led By Jaclyn Tamaroff, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once over 10 days
Awards & highlights

Study 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 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.

Eligible Conditions
  • Duchenne Muscular Dystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once over 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and once over 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of hyperglycemia
Standard deviation of the mean R-to-R segment (SDANN)
Secondary outcome measures
Activity level - measured by ActiGraph
Coefficient of variation on CGM
Rate of significant hyperglycemia
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: ControlsExperimental Treatment1 Intervention
40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).
Group II: Case - DMDExperimental Treatment1 Intervention
40 male individuals with DMD

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
858 Previous Clinical Trials
672,213 Total Patients Enrolled
Jaclyn Tamaroff, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~53 spots leftby Feb 2030