Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity

NCT ID: NCT05052073

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-01
• Study Completion Date: 2022-12-31

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).

Conditions

Various Forms of Skeletal Muscle Dystrophy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MD patients

• patients with different forms of muscle dystrophy, for example
• facioscapulohumeral dystrophy
• dysferlinopathy
• caveolinopathy

oral glucose load at rest

Intervention Type: DIAGNOSTIC_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 exercise

Intervention Type: DIAGNOSTIC_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

Controls

\- healthy age- and sex-matched controls (10 men, 10 women)

oral glucose load at rest

Intervention Type: DIAGNOSTIC_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 exercise

Intervention Type: DIAGNOSTIC_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

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Michael Boschmann

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charite University Medicine, ECRC

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Boschmann, Dr. med.

Role: CONTACT

michael.boschmann@charite.de

+49.30.450.540.241

Facility Contacts

Michael Boschmann, Dr.

Role: primary

Other Identifiers

MyoMet

Identifier Type: -

Identifier Source: org_study_id