NCT01921374

Brief Summary

The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

August 8, 2013

Last Update Submit

February 2, 2016

Conditions

Other Diseases or Conditions

Keywords

Duchenne;mothers caregivers;sleep;hormonal profile;cardiac profile;biochemical profile;inflammatory profile.

Outcome Measures

Primary Outcomes (1)

  • sleep patterns of the study population

    Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.

    Baseline

Secondary Outcomes (4)

  • Hormonal profile

    Baseline

  • Inflammatory profile

    Baseline

  • Cardiovascular profile

    Baseline

  • Metabolic profile

    Baseline

Study Arms (5)

sleep parameters

EXPERIMENTAL

To assess the sleep parameters.

Biological: sleep parameters

cardiovascular parameters

OTHER

To assess the cardiovascular profile of control mothers and caregivers-mothers.

Biological: Cardiovascular profile

imflammatory and immunological profile

EXPERIMENTAL

To assess the inflammatory profile of caregivers-mothers and control mothers

Biological: Inflammatory profile

hormonal profile

EXPERIMENTAL

To assess the hormonal profile of caregivers-mothers and control mothers.

Biological: Hormonal profile

metabolic profile

EXPERIMENTAL

To assess the health profile of caregivers-mothers and control mothers.

Biological: Metabolic profile

Interventions

sleep parametersBIOLOGICAL

Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.

sleep parameters
Hormonal profileBIOLOGICAL

To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters.

Also known as: Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Total Testosterone, Estradiol, Progesterone, Vitamin B12, Adrenocorticotropic hormone (ACTH)
hormonal profile
Inflammatory profileBIOLOGICAL

To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters

Also known as: C-reactive protein (PCR), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement (C3), Complement (C4), Interleukin 6, Interleukin 10, Interleukin 1β, Interleukin 2, Interleukin 4, Interleukin 8, Interferon-gamma (IFN-γ), Endothelin, Prostaglandin E2, Intercellular Adhesion Molecule 1 (ICAM), Vascular cell adhesion protein 1 (VCAM), Tumor necrosis factor (TNFα), Adiponectin, Leptin, Cysteine, Lymphocytes subpopulations (T e B)
imflammatory and immunological profile
Cardiovascular profileBIOLOGICAL

To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters

Also known as: Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK), Creatine kinase MB (CKMB)
cardiovascular parameters
Metabolic profileBIOLOGICAL

To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters

Also known as: Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine, Urea, Sodium, Potassium, Hemogram, Erythrocyte sedimentation rate, Natriuretic Peptide B
metabolic profile

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers-caregivers of children and adolescents with DMD
  • Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome)

You may not qualify if:

  • Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
  • Working mothers of nocturnal period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Federal of São Paulo

São Paulo, São Paulo, 04024001, Brazil

Location

Related Publications (3)

  • Donders J, Taneja C. Neurobehavioral characteristics of children with Duchenne muscular dystrophy. Child Neuropsychol. 2009 May;15(3):295-304. doi: 10.1080/09297040802665777. Epub 2009 Jan 22.

    PMID: 19160150BACKGROUND

  • Draper BM, Poulos CJ, Cole AM, Poulos RG, Ehrlich F. A comparison of caregivers for elderly stroke and dementia victims. J Am Geriatr Soc. 1992 Sep;40(9):896-901. doi: 10.1111/j.1532-5415.1992.tb01986.x.

    PMID: 1512385BACKGROUND

  • Fee RJ, Hinton VJ. Resilience in children diagnosed with a chronic neuromuscular disorder. J Dev Behav Pediatr. 2011 Nov;32(9):644-50. doi: 10.1097/DBP.0b013e318235d614.

    PMID: 22008789BACKGROUND

Related Links

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

InsulinHydrocortisoneLuteinizing HormoneFollicle Stimulating HormoneTestosteroneEstradiolProgesteroneVitamin B 12Adrenocorticotropic HormoneC-Reactive ProteinPolymerase Chain ReactionImmunoglobulin AImmunoglobulin GImmunoglobulin MComplement C3Complement C4Interleukin-6Interleukin-10Interleukin-2Interleukin-4Interleukin-8Interferon-gammaEndothelinsDinoprostoneIntercellular Adhesion Molecule-1Vascular Cell Adhesion Molecule-1Tumor Necrosis Factor-alphaAdiponectinLeptinCysteineHomocysteineMyoglobinTnni3k protein, mouseCreatine KinaseCreatine Kinase, MB FormMetabolomeGlucoseCholesterolTriglyceridesUric AcidCreatinineUreaSodiumPotassiumBlood Sedimentation5-nitro-2-(3-phenylpropylamino)benzoic acid

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex Hormones17-HydroxycorticosteroidsGonadotropins, PituitaryGonadotropinsPituitary Hormones, AnteriorPituitary HormonesAndrostenolsAndrostenesAndrostanesTestosterone CongenersGonadal Steroid HormonesGonadal HormonesEstrenesEstranesEstradiol CongenersCorpus Luteum HormonesProgesterone CongenersCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsMelanocortinsPro-OpiomelanocortinHypothalamic HormonesNeuropeptidesNerve Tissue ProteinsProteinsAlbuminsAcute-Phase ProteinsBlood ProteinsImmunoproteinsNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesImmunoglobulin IsotypesAntibodiesImmunoglobulinsSerum GlobulinsGlobulinsComplement System ProteinsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsBiological FactorsLymphokinesChemokines, CXCChemokinesChemotactic FactorsInflammation MediatorsInterferonsMacrophage-Activating FactorsProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsCell Adhesion MoleculesMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesMembrane ProteinsAntigens, SurfaceAntigensMonokinesTumor Necrosis FactorsAdipokinesAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsSulfhydryl CompoundsAmino Acids, NeutralAmino AcidsMuscle ProteinsContractile ProteinsGlobinsHemeproteinsPhosphotransferases (Nitrogenous Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesMetabolismHexosesMonosaccharidesSugarsCholestenesCholestanesSterolsMembrane LipidsGlyceridesXanthinesAlkaloidsPurinonesPurinesHeterocyclic Compounds, 2-RingImidazolesAmidesMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

July 1, 2014

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

BR(1)