NCT03945370|CompletedDMC
Oral Ketone Body Supplementation in Patients With McArdle Disease
GSDV
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GSDV
Sponsor study identifier
interventional
8
1 country
1
Study Start
May 6, 2019
Actual (reported)Primary Completion
October 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle. Investigators hypothesize that ketones can be an alternative fuel substrate for skeletal muscle when muscle glycogenolysis is blocked as in McArdle disease. In this study investigators will investigate the immediate effects of an oral supplementation of exogenous ketone bodies (poly-hydroxybuturate) on exercise capacity in patients with metabolic myopathies, compared with a placebo drink.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2019
Actual (reported)May 6, 2019
Actual (reported)May 10, 2019
Actual (reported)October 1, 2020
Actual (reported)October 1, 2020
Actual (reported)Heart rate
Change between visit 1 and 2 in mean heart rate during constant load cycling exercise (40 minute submaximal cycle test)
30 minuts x 2
Ketone metabolism
150 minuts x 2
Carbohydrate metabolism
150 minuts x 2
Fat metabolism
150 minuts x 2
Indirect calorimetry
30 minuts x 2
Perceived exertion
30 minuts x 2
Ketone drink first - Placebo drink secondly
Placebo drink first - Ketone drink secondly
Oral dietary supplement product containing β-hydroxybuturate esters
Oral placebo drink
Copenhagen Neuromuscular Center
Copenhagen, Denmark
8 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2019
First Posted
May 10, 2019
Study Start
May 6, 2019
The Effect of Triheptanoin in Adults With McArdle Disease (Glycogen Storage Disease Type V)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)Last Updated
October 6, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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