Myotonic Dystrophy 1DM-VASCOGNCT04656210
Myotonic Dystrophy - Vascular and Cognition
An observational study of Myotonic Dystrophy 1 and Diabetes, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myotonic Dystrophy 1, Diabetes, Carbohydrate Intolerance
- What is being tested?
- MRI and neuropsychological tests
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with DM type 1 monitored annually by the Neuromuscular Disease Reference Centre
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study
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).
- Conditions
- Myotonic Dystrophy 1, Diabetes, Carbohydrate Intolerance
- Being tested
- MRI, neuropsychological tests
- Keywords
- Cerebral atrophy, MRI, cognition, metabolic syndrome, tauopathy
- Medical subject headings
- Myotonic Dystrophy, Diabetes Mellitus, Glucose-Galactose Malabsorption, Metabolic Syndrome, Tauopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
Non conventional MRI (35 minutes)
neuropsychological testsOther
Standardized and quantified neuropsychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1: MD type 1 normal | patients with type 1 myotonic dystrophy with normal carbohydrate tolerance Receives: Radiation: MRI; Other: neuropsychological tests | |
| Group 2: MD type 1 Diabetes | patients with type 1 myotonic dystrophy with diabetes. Patients with carbohydrate intolerance ("pre-diabetes") who became diabetic at 3 years of age will be divided into Group 2. Receives: Radiation: MRI; Other: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrophy difference based on two cerebral MRI volumetries
difference between initial MRI and 4-year MRI
Measured: at 4 years
Secondary outcomes (3)
changes in scores at 4-year neuropsychological assessment of inclusion
difference between initial assessment and 4-year assessment
Measured: At baseline at 4 years
changes in tau biomarkers in blood at 4 years of inclusion
difference between initial and 4-year dosing
Measured: At baseline at 4 years
changes in amyloid biomarkers in blood at 4 years of inclusion
difference between initial and 4-year dosing
Measured: At baseline at 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start14 Oct 2021
- Primary completion13 Oct 2024
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myotonic Dystrophy 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline TARD, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656210
- Sponsor's protocol ID
- 2018_31
- Other IDs
- 2019-A00086-51
- Acronym
- DM-VASCOG
- Status last verified
- May 2026
- First submitted
- 23 Nov 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study
- ClinicalTrials.gov ID
- NCT04656210
- Acronym / sponsor ID
- DM-VASCOG / 2018_31
- Conditions
- Myotonic Dystrophy 1, Diabetes, Carbohydrate Intolerance
- Keywords
- Cerebral atrophy, MRI, cognition, metabolic syndrome, tauopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 13 Oct 2024 (actual)
- Study completion
- Jan 2029 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: MD type 1 normal | – | Radiation: MRI, Other: neuropsychological testspatients with type 1 myotonic dystrophy with normal carbohydrate tolerance |
| Group 2: MD type 1 Diabetes | – | Radiation: MRI, Other: neuropsychological testspatients with type 1 myotonic dystrophy with diabetes. Patients with carbohydrate intolerance ("pre-diabetes") who became diabetic at 3 years of age will be divided into Group 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DM type 1 monitored annually by the Neuromuscular Disease Reference Centre
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRINon conventional MRI (35 minutes) | Radiation | Group 1: MD type 1 normal, Group 2: MD type 1 Diabetes |
| neuropsychological testsStandardized and quantified neuropsychological assessment | Other | Group 1: MD type 1 normal, Group 2: MD type 1 Diabetes |
Primary outcome
Atrophy difference based on two cerebral MRI volumetries
Time frame: at 4 years
difference between initial MRI and 4-year MRI
3 secondary outcomes
changes in scores at 4-year neuropsychological assessment of inclusion
Time frame: At baseline at 4 years
changes in tau biomarkers in blood at 4 years of inclusion
Time frame: At baseline at 4 years
changes in amyloid biomarkers in blood at 4 years of inclusion
Time frame: At baseline at 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline TARD, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myotonic Dystrophy 1 and Diabetes, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrophy difference based on two cerebral MRI volumetries (time frame: at 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.