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Glycogen Storage DiseaseNCT04292938

McArdle Disease Treatment by Ketogenic Diet

A study testing Low carbohydrate ketogenic diet in people with Glycogen Storage Disease, run by IRCCS Eugenio Medea at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

McArdle's disease or Glycogen storage disease type 5 (GSD5), the most common muscle glycogenosis, is a rare disabling condition with no effective treatment. There are indications that a special dietary regimen could positively influence the disease manifestations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glycogen Storage Disease
What is being tested?
Low carbohydrate ketogenic diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteItaly
Study dates
25 Mar 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • molecularly defined Glycogen storage disease type 5, ability to perform a cycle ergometer exercise test

Who cannot join

  • pregnancy,
  • medical condition preventing a LCKD regimen (CPT2 or acyl-CoA deficiency, liver heart or kidney failure, unstable diabetes).

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Medea

    Conegliano, Treviso, 31015

Other trials in Italy

About this study

Official title: Ketogenic Diet in McArdle Disease: a Multicentric Single Blind Controlled Trial

McArdle's disease or Glycogen storage disease type 5 (GSD5), the most common muscle glycogenosis, is a rare disabling condition with no effective treatment. There are indications that a special dietary regimen could positively influence the disease manifestations. After contradictory indications for protein rich vs carbohydrate rich diets, several preliminary studies and more and more patients own experiences are now pointing to a low carbohydrate ketogenic diet (LCKD) as possibly effective in improving exercise tolerance and reducing muscle damage. The investigators propose a multicentre randomized single blind controlled trial testing efficacy of an individualized LCKD in GSD5. The investigators will test the ability of a 6 months dietary regimen with a 3:1 LCKD inducing a BOHB blood concentration of 1.5-4 mmol/l to improve the aerobic capacity as measured by peak VO2 at exercise testing in GSD5 patients. Thirty molecularly defined MCA adults will be enrolled: to half of them randomly selected the dietary regimen will be prescribed, while subjects in the control group will follow their usual balanced diet. The evaluators will be blinded to the diet followed by the examined patient

Read the detailed description

McArdle disease (myophosphorylase deficiency, glycogen storage disease type 5, GSD5, OMIM # 232600) is an inherited metabolic disorder of skeletal muscle. Affected patients suffer from genetically determined lack of the enzyme muscle glycogen phosphorylase, which is essential for glycogen metabolism. The condition is caused by homozygous or compound heterozygous mutations in the muscle glycogen phosphorylase gene (PYGM) located at chromosome 11q13. Many pathogenic mutations have been identified in the gene, which spans 20 exons, and many are population specific. The most common mutation in Northern Europe and North America is a nonsense mutation at Arg50stop (R50X) in exon 1 (previously referred to as R49X). A second frequent mutation in this population, and in Spanish patients, is Gly205Ser (G205S). McArdle disease is a rare disorder with an estimated incidence of 1:100,000.

Complete absence of muscle phosphorylase results in the inability to mobilize muscle glycogen stores, which are normally required as substrate for energy generation during anaerobic metabolism, which occurs during start of exercise and high-intensity efforts. In affected people, symptoms of fatigue and discomfort therefore occur within minutes of initiating any activity and during strenuous activity such as lifting heavy weights or walking uphill. If the activity is continued despite symptoms, a severe cramp (which is called a contracture in GSD5, because the muscle contraction is not caused by neural stimulation) occurs, which leads to muscle damage. If the damage is substantial, acute rhabdomyolysis may occur, which in turn can result in dark brown/black discoloration of urine (myoglobinuria). When rhabdomyolysis is severe, myoglobinuria can lead to acute renal failure, requiring treatment with dialysis.

In patients with GSD5, aerobic metabolism is limited and varies as a function of the availability of alternative fuels as a function of exercise and diet. The second wind phenomenon is illustrative. The phenomenon is characterized by the ability to increase work output after about 7-8 minutes of exercise. The second wind occurs as a consequence of increased availability and metabolism of alternative fuel substrates, preferentially glucose supplied from the liver, but also free fatty acids metabolized through oxidative phosphorylation and ketones produced by the liver. Despite these compensatory fuels, which can substitute for the absent glycogen breakdown in muscle, the capacity for oxidative phosphorylation is impaired in GSD5, because of an almost complete absence of pyruvate, a by-product of glycolysis.

Reduced oxidative phosphorylation in untrained patients with GSD5 in turn reduces oxygen consumption to approximately 35% of normal and there is a disproportionate increase in heart rate during exercise in patients with GSD5 compared with healthy controls. Thus, unconditioned people with GSD5 have very limited exercise capacity, which affects quality of life.

Most patients present in the second or third decade, although symptoms are often reported retrospectively from childhood. With advancing age a 20-25% proportion of patients develop fixed muscle weakness predominantly affecting the shoulder girdle. No clear cut genotype-phenotype correlation has been found to explain the clinical variation in severity observed even within families, but the influence of polymorphisms in other genes has been hypothesized.

Currently, there is no treatment for the condition. There have been a small number of randomized controlled treatment trials, however the largest number of participants in any previous study was 19.

Taking glucose prior to exercise alleviates muscle symptoms by inducing a 'second wind' at the onset of exercise, but has detrimental effects on weight if used too frequently. A Cochrane systematic review of training in GSD5 identified a few non-randomized trials of aerobic training or dietary manipulation either with supplements such as creatine or with shift towards lipid sources, which showed no harmful effect and suggest benefit over a number of months however long-tern results and confirmation on larger cohorts are warranted.

In spite of these indications, controlled training and dietary habits are seldom followed by patients, who experience significant limitations in activity of daily living and restriction in their participation.

A key limitation to exercise in GSD5 is the bottleneck in fuel flow through the Tri Carboxylic Acid (TCA) cycle, which is imposed by the minimal supply of glucosyl units from muscle glycogen and thus glycolytic flux to feed the TCA cycle.

Dietary manipulation has been identified since the eighties as a potential strategy to improve functioning in GSD5. In spite of initial indications for high protein regimens, later experimental comparison of high protein vs high carbohydrate diets indicated a superiority for the latter. Particular interest was also focussed on diets with predominant lipid energy source (ketogenic or low carbohydrate ketogenic LCKD) with the assumption that ketones are easily taken up by mitochondria and can substitute for the missing acyl-CoA moieties not provided by the staggering glycolysis blocked upstream for the inaccessibility of muscle glycogen. LCKD has a long history as a therapeutic strategy for several conditions (epilepsy, PDH defect, GLUT1 defect) with a good record of safety and efficacy and a poorer record of tolerability. Isolated experiences of LCKD have been carried out in GSD5 patients (maximum 4 patients) with promising results.

Being tested
Low carbohydrate ketogenic diet
Keywords
McArdle, Diet, Ketogenic
Medical subject headings
Glycogen Storage Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low carbohydrate ketogenic dietDietary supplement

    Also called Ketogenic

    Dietary modification, including the use of supplements, with the aim of reaching a lipid/carbohydrate-protein 3:1 ratio with a minimum 1g/Kg/die in protein

Study groups in NCT04292938
Study groupRoleWhat they receive
Ketogenic dietActive comparatorpatients will follow a low carbohydrate high lipid personalized diet causing blood BOHB level to be between 1.5-4 mmol/l for six months
Receives: Dietary Supplement: Low carbohydrate ketogenic diet
control groupNo interventionPatients will be asked to maintain their usual dietary regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in maximal (peak) oxidative capacity (VO2max)

    pre to post diet comparison of maximal O2 consumption attained during an incremental cycle ergometer test

    Measured: six months

Secondary outcomes (7)
  1. heart rate

    change in the maximum heart rate during constant load cycling exercise (HR const)

    Measured: six months

  2. maximal workload

    change in maximal workload capacity (Wmax) at incremental cycle ergometer test

    Measured: six months

  3. 12 min walking test

    the maximum walking distance in 12 minutes

    Measured: six months

  4. Fatigue

    self-rated severity of fatigue symptoms on a Fatigue Severity Scale (FSS). The FSS scoring is 1-7 on 9 averaged domains. 1 is minimal fatigue and 7 is maximal.

    Measured: six months

  5. Short Form 36 (SF36)

    the quality of life assessed using the 36-item Short Form Health Survey questionnaire (SF36). SF36 scoring is 0-100 with higher values indicating worse outcome

    Measured: six months

  6. Disability

    the functional disability assessed using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). WHO-DAS 2.0 scoring is 0-100 with higher scores indicating worse outcome

    Measured: six months

  7. exertion

    the rate of Perceived Exertion during constant workload cycling (RPEconst) scored on a NRS scale 0-10 where 10 is maximum pain

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start25 Mar 2019
  3. Primary completion31 Dec 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled single blind
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292938
Sponsor's protocol ID
543
Status last verified
Aug 2021
First submitted
28 Feb 2020
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymised data might be loaded on the European registry for muscle glycogenoses (EUROMAC)

Publications

  • Quinlivan R, Martinuzzi A, Schoser B. Pharmacological and nutritional treatment for McArdle disease (Glycogen Storage Disease type V). Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD003458. doi: 10.1002/14651858.CD003458.pub5.

    PubMed 25391139
  • Busch V, Gempel K, Hack A, Muller K, Vorgerd M, Lochmuller H, Baumeister FA. Treatment of glycogenosis type V with ketogenic diet. Ann Neurol. 2005 Aug;58(2):341. doi: 10.1002/ana.20565. No abstract available.

    PubMed 16049943
  • Vorgerd M, Zange J. Treatment of glycogenosys type V (McArdle disease) with creatine and ketogenic diet with clinical scores and with 31P-MRS on working leg muscle. Acta Myol. 2007 Jul;26(1):61-3.

    PubMed 17915573
  • Cai QY, Zhou ZJ, Luo R, Gan J, Li SP, Mu DZ, Wan CM. Safety and tolerability of the ketogenic diet used for the treatment of refractory childhood epilepsy: a systematic review of published prospective studies. World J Pediatr. 2017 Dec;13(6):528-536. doi: 10.1007/s12519-017-0053-2. Epub 2017 Jul 12.

    PubMed 28702868
  • Muzykewicz DA, Lyczkowski DA, Memon N, Conant KD, Pfeifer HH, Thiele EA. Efficacy, safety, and tolerability of the low glycemic index treatment in pediatric epilepsy. Epilepsia. 2009 May;50(5):1118-26. doi: 10.1111/j.1528-1167.2008.01959.x. Epub 2009 Feb 12.

    PubMed 19220406
  • Roehl K, Sewak SL. Practice Paper of the Academy of Nutrition and Dietetics: Classic and Modified Ketogenic Diets for Treatment of Epilepsy. J Acad Nutr Diet. 2017 Aug;117(8):1279-1292. doi: 10.1016/j.jand.2017.06.006.

    PubMed 28754198
  • Paoli A, Bianco A, Damiani E, Bosco G. Ketogenic diet in neuromuscular and neurodegenerative diseases. Biomed Res Int. 2014;2014:474296. doi: 10.1155/2014/474296. Epub 2014 Jul 3.

    PubMed 25101284
  • Martinuzzi A, Musumeci O, Stefan C, Vinante E, Ferrati A, Perillo C, Pesenti N, Toscano A. Low-carbohydrate ketogenic diet in Mc Ardle's disease: a single-blinded randomized controlled trial. J Neurol. 2025 Oct 15;272(10):698. doi: 10.1007/s00415-025-13405-5.

    PubMed 41094169

Questions about this trial

What is this clinical trial studying?

A study testing Low carbohydrate ketogenic diet in people with Glycogen Storage Disease, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maximal (peak) oxidative capacity (VO2max) (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292938, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.

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