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Completed

NCT Number: NCT04384354

Digestive Events in Duchenne Muscular Dystrophy Patients

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

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

15 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CICIT805

Garches, 92380, France

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all Duchenne muscular dystrophy patients in our center

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: DIGD

Important dates

Study start
2007
Primary completion
2018
Study completion
2019
First posted
May 12, 2020
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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