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.
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.
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.
- Conditions
- Glycogen Storage Disease
- 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 group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Active comparator | patients 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 group | No intervention | Patients 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.
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)
heart rate
change in the maximum heart rate during constant load cycling exercise (HR const)
Measured: six months
maximal workload
change in maximal workload capacity (Wmax) at incremental cycle ergometer test
Measured: six months
12 min walking test
the maximum walking distance in 12 minutes
Measured: six months
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
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
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
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.
- First posted3 Mar 2020
- Study start25 Mar 2019
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Glycogen Storage DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, University of Messina
- Responsible party
- Sponsor
- Investigators
- Andrea Martinuzzi, MD, PhD, Principal investigator, IRCCS E Medea
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 25391139Busch 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 16049943Vorgerd 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 17915573Cai 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 28702868Muzykewicz 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 19220406Roehl 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 28754198Paoli 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 25101284Martinuzzi 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet in McArdle Disease: a Multicentric Single Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04292938
- Acronym / sponsor ID
- 543
- Conditions
- Glycogen Storage Disease
- Keywords
- McArdle, Diet, Ketogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- University of Pisa, University of Messina
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled single blind
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Active comparator | Dietary Supplement: Low carbohydrate ketogenic dietpatients will follow a low carbohydrate high lipid personalized diet causing blood BOHB level to be between 1.5-4 mmol/l for six months |
| control group | No intervention | –Patients will be asked to maintain their usual dietary regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- molecularly defined Glycogen storage disease type 5, ability to perform a cycle ergometer exercise test
Key exclusion criteria (2 listed)
- pregnancy,
- medical condition preventing a LCKD regimen (CPT2 or acyl-CoA deficiency, liver heart or kidney failure, unstable diabetes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate ketogenic dietAlso: KetogenicDietary 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 | Dietary supplement | Ketogenic diet |
Primary outcome
Change in maximal (peak) oxidative capacity (VO2max)
Time frame: six months
pre to post diet comparison of maximal O2 consumption attained during an incremental cycle ergometer test
7 secondary outcomes
heart rate
Time frame: six months
maximal workload
Time frame: six months
12 min walking test
Time frame: six months
Fatigue
Time frame: six months
Short Form 36 (SF36)
Time frame: six months
Disability
Time frame: six months
exertion
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Results publication: PubMed 25391139Quinlivan 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.
- Results publication: PubMed 16049943Busch 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.
- Results publication: PubMed 17915573Vorgerd 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.
- Results publication: PubMed 28702868Cai 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.
- Results publication: PubMed 19220406Muzykewicz 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.
- Results publication: PubMed 28754198Roehl 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.
- Results publication: PubMed 25101284Paoli 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.
- Derived from this study: PubMed 41094169Martinuzzi 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.
- Individual participant dataSharing planned: No. Anonymised data might be loaded on the European registry for muscle glycogenoses (EUROMAC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Martinuzzi, MD, PhD principal investigator
IRCCS E Medea
1 site in 1 country: see every site and its status.
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.