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Digestive Events in Duchenne Muscular Dystrophy Patients (DIGD)

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: NCT04384354
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Crenn, Centre d'Investigation Clinique et Technologique 805

Brief Summary:
Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

Condition or disease
Duchenne Muscular Dystrophy

Detailed Description:
Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Digestive Events in Duchenne Muscular Dystrophy Patients
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 2018
Actual Study Completion Date : April 2019





Primary Outcome Measures :
  1. Incidence of digestive events [ Time Frame: 11 years ]
    Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication

  2. Prevalence of digestive events [ Time Frame: 11 years ]
    Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication

  3. Risk factors for digestive events (1) [ Time Frame: 11 years ]
    age (years)

  4. Risk factors for digestive events (2) [ Time Frame: 11 years ]
    pulmonary functional tests (vital capacity in ml/kg)

  5. Risk factors for digestive events (3) [ Time Frame: 11 years ]
    echocardiography parameters (LVEF: left ventricular ejection fraction in %)

  6. Risk factors for digestive events (4) [ Time Frame: 11 years ]
    residual dystrophin level (Western blot and/or immunohistochemistry in muscle)

  7. Risks factors for digestive events (5) [ Time Frame: 11 years ]
    genetic parameters (type of mutation, functional domain of altered dystrophin)


Secondary Outcome Measures :
  1. Nutritional status (1) [ Time Frame: 11 years ]
    Weigh (kg) and height (in m) agregated in BMI (kg/m^2)

  2. Nutritional status (2) [ Time Frame: 11 years ]
    albuminemia in g/L


Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patients, due to the specific disease (Duchenne muscular dystrophy patients)
Sampling Method:   Non-Probability Sample
Study Population
Duchenne muscular dystrophy patients
Criteria

Inclusion Criteria:

  • all Duchenne muscular dystrophy patients in our center

Exclusion Criteria:

  • none

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): NCT04384354


Locations
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France
CICIT805
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Study Chair: CICIT805 Garches APHP/UVSQ
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Responsible Party: Crenn, Professor, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT04384354    
Other Study ID Numbers: DIGDMD
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All clinician and biologist involved in the follow-up of these patients

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crenn, Centre d'Investigation Clinique et Technologique 805:
pseudo occlusion
gastrostomy
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked