Digestive Events in Duchenne Muscular Dystrophy Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04384354

Acronym

DIGD

Enrollment

200

Registered

2020-05-12

Start date

2007-01-31

Completion date

2019-04-30

Last updated

2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Keywords

pseudo occlusion, gastrostomy

Brief summary

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

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

15 Years to No maximum

Inclusion criteria

* all Duchenne muscular dystrophy patients in our center

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Risks factors for digestive events (5)	11 years	genetic parameters (type of mutation, functional domain of altered dystrophin)
Risk factors for digestive events (3)	11 years	echocardiography parameters (LVEF: left ventricular ejection fraction in %)
Risk factors for digestive events (4)	11 years	residual dystrophin level (Western blot and/or immunohistochemistry in muscle)
Incidence of digestive events	11 years	Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
Prevalence of digestive events	11 years	Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
Risk factors for digestive events (1)	11 years	age (years)
Risk factors for digestive events (2)	11 years	pulmonary functional tests (vital capacity in ml/kg)

Secondary

Measure	Time frame	Description
Nutritional status (2)	11 years	albuminemia in g/L
Nutritional status (1)	11 years	Weigh (kg) and height (in m) agregated in BMI (kg/m\^2)

Countries

France

Outcome results