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Other Diseases or ConditionsDMDKNCT01921374

Mother-caregivers of Children With Duchenne Muscular Dystrophy

A study testing sleep parameters, Hormonal profile and Inflammatory profile in people with Other Diseases or Conditions, run by Monica Levy Andersen at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Other Diseases or Conditions
What is being tested?
sleep parameters, Hormonal profile and Inflammatory profile
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
Aug 2013to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University Federal of São Paulo

    São Paulo, São Paulo, 04024001

Other trials in Brazil

About this study

Official title: Profile of 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.

Read the 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.

Being tested
sleep parameters, Hormonal profile, Inflammatory profile, Cardiovascular profile, Metabolic profile
Keywords
Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sleep parametersBiological

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

  • Hormonal profileBiological

    Also called Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)

    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.

  • Inflammatory profileBiological

    Also called C-reactive protein (PCR), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)

    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

  • Cardiovascular profileBiological

    Also called Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK)

    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

  • Metabolic profileBiological

    Also called Glucose, Total cholesterol and fractions, Triglycerides, Uric acid

    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

Study groups in NCT01921374
Study groupRoleWhat they receive
sleep parametersExperimentalTo assess the sleep parameters.
Receives: Biological: sleep parameters
cardiovascular parametersOtherTo assess the cardiovascular profile of control mothers and caregivers-mothers.
Receives: Biological: Cardiovascular profile
imflammatory and immunological profileExperimentalTo assess the inflammatory profile of caregivers-mothers and control mothers
Receives: Biological: Inflammatory profile
hormonal profileExperimentalTo assess the hormonal profile of caregivers-mothers and control mothers.
Receives: Biological: Hormonal profile
metabolic profileExperimentalTo assess the health profile of caregivers-mothers and control mothers.
Receives: Biological: Metabolic profile

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (4)

  1. 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:

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

    Measured: Baseline

  2. 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:

    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)

    Measured: Baseline

  3. 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:

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

    Measured: Baseline

  4. 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:

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01921374
Sponsor's protocol ID
DMDK
Acronym
DMDK
Status last verified
Feb 2016
First submitted
8 Aug 2013
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19160150

  • 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.

    PubMed 1512385

  • 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.

    PubMed 22008789

Questions about this trial

What is this clinical trial studying?

A study testing sleep parameters, Hormonal profile and Inflammatory profile in people with Other Diseases or Conditions, run by Monica Levy Andersen at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep patterns of the study population (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01921374, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

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