Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity

N/AUnknownNCT05052073

Charite University, Berlin, Germany60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Various Forms of Skeletal Muscle Dystrophy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Charite University Medicine, ECRC

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

muscle dialysate lactate

marker for anaerobic glycolysis

Time frame: 15 minutes intervals after glucose over three hours

muscle dialysate pyruvate

marker for aerobic glycolysis

Time frame: 15 minutes intervals after glucose over three hours

Secondary Outcomes

muscle tissue perfusion

measured by microdialysis and ethanol dial / ethanol perf ratio (no dimensions)

Time frame: 15 minutes intervals after glucose over three hours

energy expenditure

measured by indirect calorimetry either at rest (canopy device) or during exercise (metabolic chamber)

Time frame: 15 minutes intervals after glucose over three hours

Central Contacts

Michael Boschmann, Dr. med.

CONTACT

+49.30.450.540.241 michael.boschmann@charite.de

Data from ClinicalTrials.gov

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