Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity (MyoMet)

September 21, 2021 updated by: Michael Boschmann, Charite University, Berlin, Germany
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Charite University Medicine, ECRC
        • Contact:
          • Michael Boschmann, Dr.
        • Principal Investigator:
          • Michael Boschmann, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • out-patient clinic at Charité Universitätsmedizin Berlin, Campus Buch
  • University Campus of Charité Universitätsmedizin Berlin

Description

Inclusion Criteria:

  • controls: healthy, no metabolic, endocrine, neurologic or other diseases
  • patients: genetically confirmed diagnosis of muscle dystrophy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MD patients
  • patients with different forms of muscle dystrophy, for example
  • facioscapulohumeral dystrophy
  • dysferlinopathy
  • caveolinopathy
Diagnostic test: oral glucose load at rest
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.
Diagnostic test: oral glucose load and exercise
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
Controls
- healthy age- and sex-matched controls (10 men, 10 women)
Diagnostic test: oral glucose load at rest
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.
Diagnostic test: oral glucose load and exercise
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle dialysate lactate
Time Frame: 15 minutes intervals after glucose over three hours
marker for anaerobic glycolysis
15 minutes intervals after glucose over three hours
muscle dialysate pyruvate
Time Frame: 15 minutes intervals after glucose over three hours
marker for aerobic glycolysis
15 minutes intervals after glucose over three hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle tissue perfusion
Time Frame: 15 minutes intervals after glucose over three hours
measured by microdialysis and ethanol dial / ethanol perf ratio (no dimensions)
15 minutes intervals after glucose over three hours
energy expenditure
Time Frame: 15 minutes intervals after glucose over three hours
measured by indirect calorimetry either at rest (canopy device) or during exercise (metabolic chamber)
15 minutes intervals after glucose over three hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MyoMet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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