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Completed

NCT Number: NCT01921374

Mother-caregivers of Children With Duchenne Muscular Dystrophy

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.

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Key information

Conditions

Other Diseases or Conditions Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Federal of São Paulo

São Paulo, 04024001, Brazil

About this study

The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

sleep parameters

Biological

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

Hormonal profile

Biological

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.

Other names: Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Total Testosterone, Estradiol, Progesterone, Vitamin B12, Adrenocorticotropic hormone (ACTH)

Inflammatory profile

Biological

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

Other names: 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)

Cardiovascular profile

Biological

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

Other names: Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK), Creatine kinase MB (CKMB)

Metabolic profile

Biological

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

Other names: Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine, Urea, Sodium, Potassium, Hemogram, Erythrocyte sedimentation rate, Natriuretic Peptide B

Primary outcomes

  1. sleep patterns of the study population

    Time frame: Baseline

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

Secondary outcomes

  1. Hormonal profile

    Time frame: Baseline

    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:

    Insulin Cortisol Luteinizing hormone (LH) Follicle-stimulating hormone (FSH) Total Testosterone Estradiol Progesterone Vitamin B12 Adrenocorticotropic hormone (ACTH)

  2. Inflammatory profile

    Time frame: Baseline

    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:

    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)

  3. Cardiovascular profile

    Time frame: Baseline

    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:

    Homocysteine Myoglobin Cardiac troponin I Creatine kinase (CK) Creatine kinase MB (CKMB)

  4. Metabolic profile

    Time frame: Baseline

    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:

    Glucose Total cholesterol and fractions Triglycerides Uric acid Creatinine Urea Sodium Potassium Hemogram Erythrocyte sedimentation rate Natriuretic Peptide B

Sponsors and collaborators

Lead sponsor

Monica Levy Andersen

Other

Registry information

Official study title

Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy

Acronym: DMDK

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Aug 13, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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