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NCT06093100 · ClinicalTrials.gov registry record

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

A clinical trial of Duchenne Muscular Dystrophy, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
10
Enrollment target
1
Study location

NCT06093100 is a study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06093100, a study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
10 participants
Enrollment target
1
Study location

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 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.

Interventions

  • DEVICE wearable technology

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-07-10
Est. Completion 2030-12

What the Registry Record Tells You About NCT06093100

The ClinicalTrials.gov registry entry for NCT06093100 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which wearable technology is the first listed.

NCT06093100 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06093100 about?

NCT06093100 is a clinical study titled "Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim". 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, in...

What is the current status of trial NCT06093100?

This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2024-07-10. Estimated completion is 2030-12.

What conditions does trial NCT06093100 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT06093100?

The interventions under investigation include: wearable technology (DEVICE).

Who is sponsoring clinical trial NCT06093100?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06093100 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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