Digestive Events in Duchenne Muscular Dystrophy Patients

Duchenne Muscular Dystrophy Clinical Trial

— DIGD  

Official title:

Digestive Events in Duchenne Muscular Dystrophy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384354
• Other study ID #: DIGDMD
• Status: Completed
• Start date: January 2007
• Est. completion date: April 2019

Study information

• Verified date: May 2020
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Gender: Male
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• all Duchenne muscular dystrophy patients in our center

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Locations

Country	Name	City	State
France	CICIT805	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

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