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Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin
study id #: NCT02516085
condition: Duchenne Muscular Dystrophy
The purpose of the study is to show that the intake of L-arginine and metformin improves muscle function and delays disease progression in patients with Duchenne’s muscular dystrophy.
intervention: Metformin, L-Arginine
mechanism of action: Muscle cell engery regulators to prevent muscle loss
start date: January 2012
estimated completion: October 2012
phase of development: Phase 1
size / enrollment: 5
This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The study medication consists of L-arginine and metformin. The duration of the study is 16 weeks and comprehends one screening and four study visits.
- Mean change of muscle metabolism [ Time Frame: baseline to week 16 ]
mitochondrial protein expression analysis in muscular biopsies
- In vivo change of muscle metabolism [ Time Frame: baseline to week 16 ]
indirect calorimetry, Dual-Energy X-Ray Absorptiometry, quantitative thigh muscle MRI, clinical score of muscle performance
• Molecular diagnosis of DMD
• Patients 7 - 10 years of age at time of screening
• Previous (3 months or less) or concomitant participation in another therapeutic trial
• Use of L-arginine, L-citrulline or metformin within the last 3 months
• Known individual hypersensitivity to L-citrulline or metformin
• Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator
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