ClinicalTrials.gg
Active, not recruitingNCT04656210DM-VASCOGUpdated May 22, 2026

Myotonic Dystrophy - Vascular and Cognition

An observational study in Myotonic Dystrophy 1, Diabetes and Carbohydrate Intolerance, sponsored by University Hospital, Lille. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Myotonic Dystrophy 1
  • Diabetes
  • Carbohydrate Intolerance

Keywords

  • Cerebral atrophy
  • MRI
  • cognition
  • metabolic syndrome
  • tauopathy
03

In context

Myotonic Dystrophy

126 studies on the registry are indexed under Myotonic Dystrophy; 50 are open to participants now.

This study's enrollment of 85 is below the median of 100 across 56 observational studies indexed under Myotonic Dystrophy.

Browse Myotonic Dystrophy studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with DM type 1 monitored annually by the Neuromuscular Disease Reference Centre

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Molecularly proven type 1 myotonic dystrophy
  • Voluntary, having given
  • 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

Exclusion Criteria:

  • Neurological history other than neuropathy: epilepsy, stroke, dementia
  • Pregnancy or breastfeeding or woman of childbearing age without effective (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 by the investigator (cancer, unstable angina, etc.).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1: MD type 1 normal

    patients with type 1 myotonic dystrophy with normal carbohydrate tolerance

    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.

    Radiation: MRI · Other: neuropsychological tests

Interventions

  • RadiationMRI

    Non conventional MRI (35 minutes)

  • Otherneuropsychological tests

    Standardized and quantified neuropsychological assessment

06

What researchers measure

Primary outcomes

  1. Atrophy difference based on two cerebral MRI volumetries

    difference between initial MRI and 4-year MRI

    Time frame: at 4 years

Secondary outcomes

  1. changes in scores at 4-year neuropsychological assessment of inclusion

    difference between initial assessment and 4-year assessment

    Time frame: At baseline at 4 years

  2. changes in tau biomarkers in blood at 4 years of inclusion

    difference between initial and 4-year dosing

    Time frame: At baseline at 4 years

  3. changes in amyloid biomarkers in blood at 4 years of inclusion

    difference between initial and 4-year dosing

    Time frame: At baseline at 4 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Oct 2024, 35 months.

Of 36 observational studies under Myotonic Dystrophy, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 35. This study's 35 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2020
First posted
Dec 7, 2020
StartActual
Oct 14, 2021
Primary completionActual
Oct 13, 2024
CompletionEst.
Jan 2029
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04656210
Responsible party
Sponsor
First posted
Dec 7, 2020
Start date
Oct 14, 2021
Primary completion
Oct 13, 2024
Completion
Jan 2029 (estimated)
Last update
May 22, 2026

Study contacts

Céline TARD, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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