Myotonic Dystrophy - Vascular and Cognition

Diabetes Clinical Trial

— MD-VASCOG  

Official title:

Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656210
• Other study ID #: 2018_31
• Secondary ID: 2019-A00086-51
• Status: Recruiting
• Start date: October 14, 2021
• Est. completion date: January 2029

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Céline TARD, MD
• Phone: 0320445962
• Email: celine.tard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The cognitive disorders of adult forms of myotonic dystrophies type 1 are heterogeneous (impairment of executive functions, visio construction and theory of the mind, which can progress to the stage of dementia). Nevertheless, patients have very different degrees of cognitive impairment. Expansion of CTG triplets disrupts the alternative splicing of mRNAs of various proteins, including the insulin receptor and Tau protein. Type 2 diabetes, associated with peripheral insulin resistance, is therefore common in this pathology. Type 2 diabetes,could to explain the cognitive impairment of patients, through the accelerated development of brain lesions (especially tauopathy and cerebral atrophy).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Molecularly proven type 1 myotonic dystrophy
• Voluntary, having given informed consent
• Socially insured patient
• Patient willing to comply with all study procedures and duration (3 hours + MRI 35 minutes)
• Patient insured under the French social security system
• Signed consent form

Exclusion Criteria:

• Neurological history other than neuropathy: epilepsy, stroke, dementia
• Pregnancy or breastfeeding or woman of childbearing age without effective contraception (a pregnancy test will be done)
• Contra indication to MRI
• Person under guardianship or curators
• Persons of full age deprived of their liberties by a judicial or administrative decision
• Major comorbidity considered as a contraindication by the investigator (cancer, unstable angina, etc.).

Related Conditions & MeSH terms

• Carbohydrate Intolerance
• Diabetes
• Myotonic Dystrophy
• Myotonic Dystrophy 1

Intervention

Radiation:
• MRI
Non conventional MRI (35 minutes)

Other:
• neuropsychological tests
Standardized and quantified neuropsychological assessment

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrophy difference based on two cerebral MRI volumetries	difference between initial MRI and 4-year MRI	at 4 years
Secondary	changes in scores at 4-year neuropsychological assessment of inclusion	difference between initial assessment and 4-year assessment	At baseline at 4 years
Secondary	changes in tau biomarkers in blood at 4 years of inclusion	difference between initial and 4-year dosing	At baseline at 4 years
Secondary	changes in amyloid biomarkers in blood at 4 years of inclusion	difference between initial and 4-year dosing	At baseline at 4 years