[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525627":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":58,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Case - DMD",null,"40 male individuals with DMD",[13],"Device: wearable technology",{"label":15,"type":10,"description":16,"interventionNames":17},"Controls","40 matched controls (gender, age ± 1 year, BMI category, self-reported race\u002Fethnicity).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","wearable technology","Three wearable devices",[9,15],[25,26,27],"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",[29],{"name":30,"affiliation":5,"role":31},"Jaclyn Tamaroff, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","615-875-7853","Jaclyn.tamaroff@vumc.org",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Andrea Lee, MA, MLS","615-875-9602","Andrea.e.lee@vumc.org",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.78444,36.16589,{"lat":53,"lon":52},[56,57],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},{"type":31,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jaclyn Tamaroff","Assistant Professor of Pediatrics","100525627","wearable-technology-to-evaluate-hyperglycemia-and-hrv-in-dmd-100525627",false,"NCT06124196","Wearable Technology to Evaluate Hyperglycemia and HRV in DMD","Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy","CASE, DMD inclusion criteria:\n\n* Male\n* Age ≥10years\n* Clinical phenotype of DMD confirmed with muscle biopsy or genotype.\n* Informed consent for individuals ≥18 years\n* Parent\u002Fguardian informed consent and child assent for individuals \\\u003C 18 years\n\nCASE, DMD exclusion criteria:\n\n* Refusal to participate.\n* Diagnosis of diabetes prior to the study and\u002For taking insulin or other anti-diabetic drug therapy in \\\u003C 4 weeks prior to treatment\n* Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device\n* Unable to comply with study procedures, in the opinion of the investigator.\n\nCONTROL inclusion criteria:\n\n* Male\n* Age ≥10years\n* Informed consent for individuals ≥18 years\n* Parent\u002Fguardian informed consent and child assent for individuals \\\u003C 18 years\n* BMI matched by Centers for Disease Control and Prevention (CDC) category (underweight, normal, overweight, obese) to cases.\n* Self-reported race\u002Fethnicity matched to cases.\n* No known evidence of diabetes, impaired fasting glucose, or impaired glucose tolerance:\n* 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.\n* Participants will be included if they have a normal HbA1c (\\\u003C 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 \\\u003C100mg\u002FdL and 2-hour glucose \\\u003C140mg\u002FdL).\n\nCONTROL, exclusion criteria:\n\n* Refusal to participate.\n* Diagnosis of diabetes prior to the study and\u002For taking insulin or other anti-diabetic drug therapy in \\\u003C 4 weeks prior to treatment\n* Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device\n* Unable to comply with study procedures, in the opinion of the investigator.\n* Diagnosis of DMD or Becker muscular dystrophy",true,"MALE","10 Years",{"count":72,"type":73},80,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[77],"Duchenne Muscular Dystrophy",[77,79,80,81,82,83,84],"heart failure","cardiomyopathy","hyperglycemia","heart rate variability","remote","controls","2026-05-19",{"date":87,"type":88},"2026-05-22","ACTUAL",{"date":90,"type":88},"2024-03-20",{"date":92,"type":73},"2031-02",{"name":5,"class":6},1]