- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921374
Mother-caregivers of Children With Duchenne Muscular Dystrophy (DMDK)
Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 04024001
- University Federal of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sleep parameters
To assess the sleep parameters.
|
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
|
Other: cardiovascular parameters
To assess the cardiovascular profile of control mothers and caregivers-mothers.
|
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:
|
Experimental: imflammatory and immunological profile
To assess the inflammatory profile of caregivers-mothers and control mothers
|
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:
|
Experimental: hormonal profile
To assess the hormonal profile of caregivers-mothers and control mothers.
|
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:
|
Experimental: metabolic profile
To assess the health profile of caregivers-mothers and control mothers.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
Baseline
|
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) |
Baseline
|
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) |
Baseline
|
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 |
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- Disease
- Muscular Dystrophies
- Muscular Dystrophy, Duchenne
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens
- Micronutrients
- Adjuvants, Immunologic
- Vitamins
- Reproductive Control Agents
- Antioxidants
- Vitamin B Complex
- Oxytocics
- Progestins
- Androgens
- Interferons
- Antibodies
- Follicle Stimulating Hormone
- Immunoglobulins
- Immunoglobulins, Intravenous
- Estradiol
- Interferon-gamma
- Hormones
- Vitamin B 12
- Progesterone
- Testosterone
- Immunoglobulin G
- Interleukin-2
- Dinoprostone
- Immunoglobulin M
- Adrenocorticotropic Hormone
- Complement System Proteins
- Melanocyte-Stimulating Hormones
- beta-Endorphin
- Uric Acid
- Interleukin-4
- Immunoglobulin A
Other Study ID Numbers
- DMDK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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