Various Forms of Skeletal Muscle DystrophyMyoMetNCT05052073
Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity
An observational study of Various Forms of Skeletal Muscle Dystrophy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this project to characterize systemic and organ-specific (subcutaneous adipose tissue and skeletal muscle) metabolic responses at rest and during standardized, moderate exercise after an oral glucose load in patients with various geneticaly heritable foms of skeletal muscle dystrophies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Various Forms of Skeletal Muscle Dystrophy
- What is being tested?
- oral glucose load at rest and oral glucose load and exercise
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2009to 31 Dec 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * out-patient clinic at Charité Universitätsmedizin Berlin, Campus Buch * University Campus of Charité Universitätsmedizin Berlin
Who may be able to join
- controls: healthy, no metabolic, endocrine, neurologic or other diseases
- patients: genetically confirmed diagnosis of muscle dystrophy
Who cannot join
- known hemorrhagic diseases / coagulopathies
- intake of oral anti-coagulant drugs (control of PTT, INR and platelet count before study entry)
- insulin-dependent Diabetes mellitus
- pregnancy and lactation period
- chronic use of non-steroidal antiphlogistics
- alcohol and drug abuse
- Claustrophobia • gleichzeitige Teilnahme an einer anderen Studie; Teilnahme an einer Studie vor weniger als zwei Monaten Unfähigkeit, die mündlichen und schriftlichen Informationen zur Studie zu verstehen und das schriftliche Einverständnis zu geben
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University Medicine, ECRC
Berlin, 13125
Michael Boschmann, Dr.
Michael Boschmann, Dr.
About this study
The aim of this project to characterize systemic and organ-specific (subcutaneous adipose tissue and skeletal muscle) metabolic responses at rest and during standardized, moderate exercise after an oral glucose load in patients with various geneticaly heritable foms of skeletal muscle dystrophies. Metabolic responses will be monitored by indirect calorimetry (canopy and/or metabolic chamber at rest and during exercise) and microdialysis (adipose tissue and skeletal muscle at rest) before and after an oral glucose load (75 g).
- Being tested
- oral glucose load at rest, oral glucose load and exercise
- Keywords
- muscle dystrophy, energy metabolism, calorimetry, metabolic chamber, microdialysis, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose load at restDiagnostic test
oral glucose load (75 g) after an 12h overnight fast at rest accompanied by blood sampling and dialysate sampling (adipose tissue and skeletal muscle), and calorimetry (canopy) over three hours.
oral glucose load and exerciseDiagnostic test
oral glucose load (75 g) after an 12h overnight fast followed by a defined (0.5 W / kg), moderate bicycle exercise i a metabolic chamber
| Study group | Role | What they receive |
|---|---|---|
| MD patients | * patients with different forms of muscle dystrophy, for example
* facioscapulohumeral dystrophy
* dysferlinopathy
* caveolinopathy Receives: Diagnostic Test: oral glucose load at rest; Diagnostic Test: oral glucose load and exercise | |
| Controls | - healthy age- and sex-matched controls (10 men, 10 women) Receives: Diagnostic Test: oral glucose load at rest; Diagnostic Test: oral glucose load and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle dialysate lactate
marker for anaerobic glycolysis
Measured: 15 minutes intervals after glucose over three hours
muscle dialysate pyruvate
marker for aerobic glycolysis
Measured: 15 minutes intervals after glucose over three hours
Secondary outcomes (2)
muscle tissue perfusion
measured by microdialysis and ethanol dial / ethanol perf ratio (no dimensions)
Measured: 15 minutes intervals after glucose over three hours
energy expenditure
measured by indirect calorimetry either at rest (canopy device) or during exercise (metabolic chamber)
Measured: 15 minutes intervals after glucose over three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Sep 2009
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Various Forms of Skeletal Muscle DystrophyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Boschmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052073
- Sponsor's protocol ID
- MyoMet
- Acronym
- MyoMet
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT05052073
- Acronym / sponsor ID
- MyoMet / MyoMet
- Keywords
- muscle dystrophy, energy metabolism, calorimetry, metabolic chamber, microdialysis, exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Sep 2021 (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 aim of this project to characterize systemic and organ-specific (subcutaneous adipose tissue and skeletal muscle) metabolic responses at rest and during standardized, moderate exercise after an oral glucose load in patients with various geneticaly heritable foms of skeletal muscle dystrophies. Metabolic responses will be monitored by indirect calorimetry (canopy and/or metabolic chamber at rest and during exercise) and microdialysis (adipose tissue and skeletal muscle at rest) before and after an oral glucose load (75 g).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD patients | – | Diagnostic Test: oral glucose load at rest, Diagnostic Test: oral glucose load and exercise* patients with different forms of muscle dystrophy, for example * facioscapulohumeral dystrophy * dysferlinopathy * caveolinopathy |
| Controls | – | Diagnostic Test: oral glucose load at rest, Diagnostic Test: oral glucose load and exercise- healthy age- and sex-matched controls (10 men, 10 women) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * out-patient clinic at Charité Universitätsmedizin Berlin, Campus Buch * University Campus of Charité Universitätsmedizin Berlin
Key inclusion criteria (2 listed)
- controls: healthy, no metabolic, endocrine, neurologic or other diseases
- patients: genetically confirmed diagnosis of muscle dystrophy
Key exclusion criteria (7 listed)
- known hemorrhagic diseases / coagulopathies
- intake of oral anti-coagulant drugs (control of PTT, INR and platelet count before study entry)
- insulin-dependent Diabetes mellitus
- pregnancy and lactation period
- chronic use of non-steroidal antiphlogistics
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 |
|---|---|---|
| oral glucose load at restoral glucose load (75 g) after an 12h overnight fast at rest accompanied by blood sampling and dialysate sampling (adipose tissue and skeletal muscle), and calorimetry (canopy) over three hours. | Diagnostic test | Controls, MD patients |
| oral glucose load and exerciseoral glucose load (75 g) after an 12h overnight fast followed by a defined (0.5 W / kg), moderate bicycle exercise i a metabolic chamber | Diagnostic test | Controls, MD patients |
Primary outcome
muscle dialysate lactate
Time frame: 15 minutes intervals after glucose over three hours
marker for anaerobic glycolysis
muscle dialysate pyruvate
Time frame: 15 minutes intervals after glucose over three hours
marker for aerobic glycolysis
2 secondary outcomes
muscle tissue perfusion
Time frame: 15 minutes intervals after glucose over three hours
energy expenditure
Time frame: 15 minutes intervals after glucose over three hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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.
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 Various Forms of Skeletal Muscle Dystrophy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Sep 2021. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Boschmann, Dr. med. (+49.30.450.540.241, michael.boschmann@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle dialysate lactate (time frame: 15 minutes intervals after glucose over three hours). The study lists 2 primary outcomes in all. 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 Sep 2021.