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NCT06124196 · ClinicalTrials.gov registry record

Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

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

Recruiting
Registry status
80
Enrollment target
1
Study location

NCT06124196 is a study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 80 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06124196, a study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
80 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-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.

Interventions

  • DEVICE wearable technology

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-03-20
Est. Completion 2031-02

What the Registry Record Tells You About NCT06124196

The ClinicalTrials.gov registry entry for NCT06124196 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (81% 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.

NCT06124196 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06124196 about?

NCT06124196 is a clinical study titled "Wearable Technology to Evaluate Hyperglycemia and HRV in DMD". 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 NCT06124196?

This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2024-03-20. Estimated completion is 2031-02.

What conditions does trial NCT06124196 study?

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

What interventions are being tested in trial NCT06124196?

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

Who is sponsoring clinical trial NCT06124196?

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

Where is trial NCT06124196 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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