Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity

• Conditions: Various Forms of Skeletal Muscle Dystrophy
• Interventions: Diagnostic Test: oral glucose load at rest; Diagnostic Test: oral glucose load and exercise

• Registration Number: NCT05052073
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MD patients	oral glucose load at rest	* patients with different forms of muscle dystrophy, for example * facioscapulohumeral dystrophy * dysferlinopathy * caveolinopathy
MD patients	oral glucose load and exercise	* patients with different forms of muscle dystrophy, for example * facioscapulohumeral dystrophy * dysferlinopathy * caveolinopathy
Controls	oral glucose load at rest	- healthy age- and sex-matched controls (10 men, 10 women)
Controls	oral glucose load and exercise	- healthy age- and sex-matched controls (10 men, 10 women)

Primary Outcome Measures

Name	Time	Method
muscle dialysate lactate	15 minutes intervals after glucose over three hours	marker for anaerobic glycolysis
muscle dialysate pyruvate	15 minutes intervals after glucose over three hours	marker for aerobic glycolysis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charite University Medicine, ECRC; 🇩🇪 Berlin, Germany