Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 10
Healthy Volunteers: t
View:

• 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

• 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).

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Jaclyn Tamaroff, MD
Jaclyn.tamaroff@vumc.org
615-875-7853
Backup
Andrea Lee, MA, MLS
Andrea.e.lee@vumc.org
615-875-9602
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2031-02
Participants
Target number of participants: 80
Treatments
Case - DMD
40 male individuals with DMD
Controls
40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov