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Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02541292
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Julia Dahlqvist, MD, Rigshospitalet, Denmark

Tracking Information
First Submitted Date September 2, 2015
First Posted Date September 4, 2015
Last Update Posted Date September 3, 2018
Study Start Date February 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2015)
  • Muscle inflammation [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]
    MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.
  • Muscle fat fraction [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]
    The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02541292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 2, 2015)
Muscle strength [ Time Frame: One muscle strength test per subject (exam lasts approximately 60 min.) ]
Isokinetic muscle dynamometry will be used to measure muscle strength.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
Official Title Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
Brief Summary

Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.

The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.

Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Persons in Denmark diagnosed with FSHD is invited to the study.
Condition Facioscapulohumeral Muscular Dystrophy 1a
Intervention Other: No intervention, observational
Study Groups/Cohorts Patient group
Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy).
Intervention: Other: No intervention, observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 27, 2017)
10
Original Estimated Enrollment
 (submitted: September 2, 2015)
15
Estimated Study Completion Date November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed FSHD

Exclusion Criteria:

  • All contraindications for undergoing an MRI scan
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02541292
Other Study ID Numbers H-15009760
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Julia Dahlqvist, MD, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date August 2018