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Trial record 31 of 32 for:    Interleukin-10

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01921374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • 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)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
  • Hormonal profile [ Time Frame: Baseline ]
    Insulin Cortisol Luteinizing hormone (LH) Follicle-stimulating hormone (FSH) Total Testosterone Estradiol Progesterone Vitamin B12 Adrenocorticotropic hormone (ACTH)
  • Inflammatory profile [ Time Frame: Baseline ]
    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)
  • Cardiac profile [ Time Frame: Baseline ]
    Homocysteine Myoglobin Cardiac troponin I Creatine kinase (CK) Creatine kinase MB (CKMB)
  • Biochemical profile [ Time Frame: Baseline ]
    Glucose Total cholesterol and fractions Triglycerides Uric acid Creatinine Urea Sodium Potassium Hemogram Erythrocyte sedimentation rate Natriuretic Peptide B
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mother-caregivers of Children With Duchenne Muscular Dystrophy
Official Title  ICMJE Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Condition  ICMJE Other Diseases or Conditions
Intervention  ICMJE
  • Biological: sleep parameters
    Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
  • 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)
  • 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)
  • 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)
  • 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
Study Arms  ICMJE
  • Experimental: sleep parameters
    To assess the sleep parameters.
    Intervention: Biological: sleep parameters
  • cardiovascular parameters
    To assess the cardiovascular profile of control mothers and caregivers-mothers.
    Intervention: Biological: Cardiovascular profile
  • Experimental: imflammatory and immunological profile
    To assess the inflammatory profile of caregivers-mothers and control mothers
    Intervention: Biological: Inflammatory profile
  • Experimental: hormonal profile
    To assess the hormonal profile of caregivers-mothers and control mothers.
    Intervention: Biological: Hormonal profile
  • Experimental: metabolic profile
    To assess the health profile of caregivers-mothers and control mothers.
    Intervention: Biological: Metabolic profile
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921374
Other Study ID Numbers  ICMJE DMDK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monica Levy Andersen, Federal University of São Paulo
Study Sponsor  ICMJE Monica Levy Andersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of São Paulo
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP