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Trial record 31 of 32 for:    Interleukin-10

Mother-caregivers of Children With Duchenne Muscular Dystrophy (DMDK)

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ClinicalTrials.gov Identifier: NCT01921374
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Monica Levy Andersen, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Other Diseases or Conditions Biological: sleep parameters Biological: Hormonal profile Biological: Inflammatory profile Biological: Cardiovascular profile Biological: Metabolic profile Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
Study Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : July 2014


Arm Intervention/treatment
Experimental: sleep parameters
To assess the sleep parameters.
Biological: sleep parameters
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.

cardiovascular parameters
To assess the cardiovascular profile of control mothers and caregivers-mothers.
Biological: Cardiovascular profile
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)

Experimental: imflammatory and immunological profile
To assess the inflammatory profile of caregivers-mothers and control mothers
Biological: Inflammatory profile
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)

Experimental: hormonal profile
To assess the hormonal profile of caregivers-mothers and control mothers.
Biological: Hormonal profile
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)

Experimental: metabolic profile
To assess the health profile of caregivers-mothers and control mothers.
Biological: Metabolic profile
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 Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921374


Locations
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Brazil
University Federal of São Paulo
São Paulo, Brazil, 04024001
Sponsors and Collaborators
Monica Levy Andersen

Additional Information:
Publications:
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Responsible Party: Monica Levy Andersen, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01921374     History of Changes
Other Study ID Numbers: DMDK
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016

Keywords provided by Monica Levy Andersen, Federal University of São Paulo:
Duchenne;
mothers caregivers;
sleep;
hormonal profile;
cardiac profile;
biochemical profile;
inflammatory profile.

Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Disease
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Hormones
Testosterone
Progesterone
Follicle Stimulating Hormone
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
Immunoglobulins
Antibodies
Complement System Proteins
Immunoglobulin G
Immunoglobulin A
Interleukin-4
Immunoglobulin M
Vitamin B 12
Interferon-gamma
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens