Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim

NCT06093100 | Recruiting

• 1 other identifier: 231407
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 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 related CM. Despite risk factors for hyperglycemia, including the use of glucocorticoids, low muscle mass, 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. In this Aim of the study, the investigators will assess the utility of remote wearable technology to predict changes in traditional metrics of metabolism and cardiac function. In this pilot study, 10 individuals with DMD will undergo cardiac magnetic resonance imaging (CMR) and oral glucose tolerance tests (OGTTs) at baseline and two years. The investigators will remotely assess glycemia (using continuous glucose monitors), HRV (using extended Holter monitors), and activity (using accelerometers) every 6 months over the 2 years and evaluate if changes in wearable metrics predict changes in CMR and OGTT.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; heart failure; cardiomyopathy; hyperglycemia; heart rate variability

Outcome Measures

Primary Outcomes (2)

• Rate of hyperglycemia

  number of glucose measurements ≥140mg/dL over total number of glucoses

  5 time points, each over 10 days

• Standard deviation of the mean R-to-R segment (SDANN)

  correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability

  5 time points, each over 7 days

Secondary Outcomes (7)

• Coefficient of variation on CGM

  5 time points, each over 10 days

• Rate of significant hyperglycemia

  5 time points, each over 10 days

• Activity level

  5 time points, each over 7 days

• Standard deviation of normal R to R intervals (SDNN)

  5 time points, each over 7 days

• Late gadolinium enhancement (LGE)

  2 time points: initially and approximately 2 years later

Interventions

wearable technology DEVICE

Three wearable devices

Also known as: Continuous glucose monitor (CGM): The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System), Holter Monitor: Body Guardian Mini Remote Monitoring System, Physical activity and sleep monitor: ActiGraph GT9X accelerometers

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: DMD is an X-linked disorder affecting approximately 1/3500-6000 males and 1/50 million females. Therefore, only males will be included in this study. Investigators will not obtain confirmation of biological sex and accept all participants as they self-identify.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 adolescent and young adult males with DMD. DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Heart Failure; Cardiomyopathies; Hyperglycemia

Interventions

Wearable Electronic Devices; Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jaclyn Tamaroff, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclyn Tamaroff, MD

CONTACT

615-875-7853; Jaclyn.tamaroff@vumc.org

Andrea Lee, MA, MLS

CONTACT

615-875-9602; Andrea.e.lee@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: July 10, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)