Glycogen Storage Disease IIIANCT03011203
Acute Nutritional Ketosis in GSD IIIa
A study testing physical exercise in people with Glycogen Storage Disease IIIA, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can boost muscle mitochondrial function in vivo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glycogen Storage Disease IIIA
- What is being tested?
- physical exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2017to 23 Mar 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GSD III confirmed with enzyme assay and/or AGL mutation analysis and GSD IIIa further specified as deficient debranching enzyme activity in muscle or clinical and/or biochemical signs of cardiac and/or skeletal muscular involvement.
Who cannot join
- contraindications for MRI studies (assessed by standardised questionnaire)
- inability to perform bicycle exercise.
- intercurrent illness which may influence exercise tolerance (anemia, musculoskeletal injury, or other undiagnosed illness under investigation).
- known coronary artery disease, positive history for angina or cardiomyopathy.
- insulin-dependent diabetes mellitus.
- loss of, or an inability to give informed consent.
- pregnancy or current breastfeeding.
- any other cause which in the opinion of the investigators, may affect the participant's ability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Nutritional Ketosis and Exercise in Glycogen Storage Disease Type IIIa
The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.
Read the detailed description
Glycogen Storage Disease type IIIa (GSD IIIa) is an inborn error of carbohydrate metabolism caused by impaired glycogen debranching enzyme (GDE) activity. The ageing GSD IIIa cohort shows that muscle involvement -despite dietary management- is a common disabling phenotype in adulthood. Currently, no specific therapy has been established for muscle problems in adult GSD IIIa patients.
However, it could be hypothesized that nutritional ketosis (NK) will be highly beneficial to patients. Amongst others, ketone bodies could take on the role of primary energy source in exercising muscle. Recently, acute NK in exercise was studied in humans. NK was found to enhance muscle mitochondrial function in athletes.
The investigators will study if acute NK in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.
- Conditions
- Glycogen Storage Disease IIIA
- Being tested
- physical exercise
- Keywords
- glycogen storage disease type IIIa, exercise, ketone esters, magnetic resonance spectroscopy
- Medical subject headings
- Glycogen Storage Disease IIIA, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseOther
In session II and III participants will perform an exercise test on a bicycle inside and outside the MR scanner.
| Study group | Role | What they receive |
|---|---|---|
| Ketone-ester drink | Experimental | Oral intake - physical exercise Receives: Other: physical exercise |
| Carbohydrate drink | Active comparator | Oral intake - physical exercise Receives: Other: physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of in vivo energy and proton balance during exercise in MR scanner with and without ketone ester drink: steady-state intramuscular levels of glycogen, Pi, PCr and pH and kinetic rate constant of metabolic recovery.
Measured: 10 minutes; during in-magnet exercise test of session II and III.
Secondary outcomes (20)
time of individual desired workload
#minutes
Measured: through completion of the maximum exercise test (of approximately 12 minutes) during study session I.
completion of supine bicycling bout at desired workload in scanner
(yes/no; if no, #minutes)
Measured: 10 min
Muscle ultrasound density of the biceps, quadriceps, calf (gastrocnemius and/or soleus) and tibialis anterior muscles.
Will be performed during study session I by a neurologist.
Measured: Together with the muscle force examination this assessment will take 1.5 hour.
Muscle force unilateral
Will be performed during study session I by a neurologist.
Measured: Together with the muscle ultrasound this assessment will take 1.5 hour.
Subjective fatigue and muscle ache score
scale 0-10
Measured: after each exercise bout and 24 hours after exercise
International Physical Activity Questionnaire
Measured: This questionnaire will take 10 minutes to fill out. Participants will be asked to fill out the questionnaire one week before study session II and III
Structural muscle parameters: fat infiltration.
Measured: During the in-magnet exercise test of 10 minutes during session II and III
Change in blood glucose levels
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood ketones level (β-hydroxybutyrate, acetoacetate).
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Change of blood pH
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of free fatty acids
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of insulin
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of creatine kinase
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of ammonia
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of NT-proBNP
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of lactate
#1 and #2 at baseline, #3 after 10 min, #4 after 15 minutes, #5 at the start of bicycle exercise test inside scanner, #6 after 10 minutes of in-magnet exercise and #7 three hours post-exercise inside scanner.
Measured: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Change of urine levels of myoglobin, ketones, tetraglucoside
Measured: Urine will be collected through study session II and III. A study session will take place from 8 am till 2 pm.
optional: muscle metabolic profile (according to Cox et. al. 2016] of a muscle biopsy.
optional, on a patient-voluntary basis. If consent has been given a total of 4 muscle biopsies will be performed.
Measured: This procedure takes 30 minutes each time and will be performed prior to and immediately post-exercise during study session II and III.
optional: individual phenotypic muscle properties (fiber type, mitochondrial density, capillary density
optional, on a patient-voluntary basis. If consent has been given a total of 4 muscle biopsies will be performed.
Measured: This procedure takes 30 minutes each time and will be performed prior to and immediately post-exercise during study session II and III.
Individual physical performance during exercise; VO2 and VCO2 dynamics.
Measured: During session I; the maximum exercise test of approximately 12 minutes and during the exercise tests of 15 minutes outside the MR scanner at session II and III.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start10 Feb 2017
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glycogen Storage Disease IIIAStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Faroe Islands, University of Oxford, Stichting Stofwisselkracht, Stichting Metakids
- Responsible party
- Principal investigator, Terry G.J. Derks, MD, PhD, University Medical Center Groningen
- Investigators
- T.G.J. Derks, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011203
- Sponsor's protocol ID
- NL59081.042.16
- Status last verified
- Apr 2018
- First submitted
- 22 Dec 2016
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.
PubMed 27475046Diekman EF, Visser G, Schmitz JP, Nievelstein RA, de Sain-van der Velden M, Wardrop M, Van der Pol WL, Houten SM, van Riel NA, Takken T, Jeneson JA. Altered Energetics of Exercise Explain Risk of Rhabdomyolysis in Very Long-Chain Acyl-CoA Dehydrogenase Deficiency. PLoS One. 2016 Feb 16;11(2):e0147818. doi: 10.1371/journal.pone.0147818. eCollection 2016.
PubMed 26881790Sentner CP, Hoogeveen IJ, Weinstein DA, Santer R, Murphy E, McKiernan PJ, Steuerwald U, Beauchamp NJ, Taybert J, Laforet P, Petit FM, Hubert A, Labrune P, Smit GPA, Derks TGJ. Glycogen storage disease type III: diagnosis, genotype, management, clinical course and outcome. J Inherit Metab Dis. 2016 Sep;39(5):697-704. doi: 10.1007/s10545-016-9932-2. Epub 2016 Apr 22.
PubMed 27106217Verbeek RJ, Sentner CP, Smit GP, Maurits NM, Derks TG, van der Hoeven JH, Sival DA. Muscle Ultrasound in Patients with Glycogen Storage Disease Types I and III. Ultrasound Med Biol. 2016 Jan;42(1):133-42. doi: 10.1016/j.ultrasmedbio.2015.08.013. Epub 2015 Oct 3.
PubMed 26437929Preisler N, Laforet P, Madsen KL, Prahm KP, Hedermann G, Vissing CR, Galbo H, Vissing J. Skeletal muscle metabolism is impaired during exercise in glycogen storage disease type III. Neurology. 2015 Apr 28;84(17):1767-71. doi: 10.1212/WNL.0000000000001518. Epub 2015 Apr 1.
PubMed 25832663Hoogeveen IJ, de Boer F, Boonstra WF, van der Schaaf CJ, Steuerwald U, Sibeijn-Kuiper AJ, Vegter RJK, van der Hoeven JH, Heiner-Fokkema MR, Clarke KC, Cox PJ, Derks TGJ, Jeneson JAL. Effects of acute nutritional ketosis during exercise in adults with glycogen storage disease type IIIa are phenotype-specific: An investigator-initiated, randomized, crossover study. J Inherit Metab Dis. 2021 Jan;44(1):226-239. doi: 10.1002/jimd.12302. Epub 2020 Sep 7.
PubMed 33448466
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Nutritional Ketosis and Exercise in Glycogen Storage Disease Type IIIa
- ClinicalTrials.gov ID
- NCT03011203
- Acronym / sponsor ID
- NL59081.042.16
- Conditions
- Glycogen Storage Disease IIIA
- Keywords
- glycogen storage disease type IIIa, exercise, ketone esters, magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of the Faroe Islands, University of Oxford, Stichting Stofwisselkracht, Stichting Metakids
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.
Detailed description
Glycogen Storage Disease type IIIa (GSD IIIa) is an inborn error of carbohydrate metabolism caused by impaired glycogen debranching enzyme (GDE) activity. The ageing GSD IIIa cohort shows that muscle involvement -despite dietary management- is a common disabling phenotype in adulthood. Currently, no specific therapy has been established for muscle problems in adult GSD IIIa patients.
However, it could be hypothesized that nutritional ketosis (NK) will be highly beneficial to patients. Amongst others, ketone bodies could take on the role of primary energy source in exercising muscle. Recently, acute NK in exercise was studied in humans. NK was found to enhance muscle mitochondrial function in athletes.
The investigators will study if acute NK in adult GSD IIIa patients can boost muscle mitochondrial function in vivo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone-ester drink | Experimental | Other: physical exerciseOral intake - physical exercise |
| Carbohydrate drink | Active comparator | Other: physical exerciseOral intake - physical exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GSD III confirmed with enzyme assay and/or AGL mutation analysis and GSD IIIa further specified as deficient debranching enzyme activity in muscle or clinical and/or biochemical signs of cardiac and/or skeletal muscular involvement.
Key exclusion criteria (8 listed)
- contraindications for MRI studies (assessed by standardised questionnaire)
- inability to perform bicycle exercise.
- intercurrent illness which may influence exercise tolerance (anemia, musculoskeletal injury, or other undiagnosed illness under investigation).
- known coronary artery disease, positive history for angina or cardiomyopathy.
- insulin-dependent diabetes mellitus.
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 |
|---|---|---|
| physical exerciseIn session II and III participants will perform an exercise test on a bicycle inside and outside the MR scanner. | Other | Carbohydrate drink, Ketone-ester drink |
Primary outcome
Description of in vivo energy and proton balance during exercise in MR scanner with and without ketone ester drink: steady-state intramuscular levels of glycogen, Pi, PCr and pH and kinetic rate constant of metabolic recovery.
Time frame: 10 minutes; during in-magnet exercise test of session II and III.
20 secondary outcomes
time of individual desired workload
Time frame: through completion of the maximum exercise test (of approximately 12 minutes) during study session I.
completion of supine bicycling bout at desired workload in scanner
Time frame: 10 min
Muscle ultrasound density of the biceps, quadriceps, calf (gastrocnemius and/or soleus) and tibialis anterior muscles.
Time frame: Together with the muscle force examination this assessment will take 1.5 hour.
Muscle force unilateral
Time frame: Together with the muscle ultrasound this assessment will take 1.5 hour.
Subjective fatigue and muscle ache score
Time frame: after each exercise bout and 24 hours after exercise
International Physical Activity Questionnaire
Time frame: This questionnaire will take 10 minutes to fill out. Participants will be asked to fill out the questionnaire one week before study session II and III
Structural muscle parameters: fat infiltration.
Time frame: During the in-magnet exercise test of 10 minutes during session II and III
Change in blood glucose levels
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood ketones level (β-hydroxybutyrate, acetoacetate).
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Change of blood pH
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of free fatty acids
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of insulin
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of creatine kinase
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of ammonia
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of NT-proBNP
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Blood levels of lactate
Time frame: Up to 7 samples will be taken during the 25 minutes exercise test (session II and III).
Change of urine levels of myoglobin, ketones, tetraglucoside
Time frame: Urine will be collected through study session II and III. A study session will take place from 8 am till 2 pm.
optional: muscle metabolic profile (according to Cox et. al. 2016] of a muscle biopsy.
Time frame: This procedure takes 30 minutes each time and will be performed prior to and immediately post-exercise during study session II and III.
optional: individual phenotypic muscle properties (fiber type, mitochondrial density, capillary density
Time frame: This procedure takes 30 minutes each time and will be performed prior to and immediately post-exercise during study session II and III.
Individual physical performance during exercise; VO2 and VCO2 dynamics.
Time frame: During session I; the maximum exercise test of approximately 12 minutes and during the exercise tests of 15 minutes outside the MR scanner at session II and III.
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 1 May 2018.
- Background: PubMed 27475046Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.
- Background: PubMed 26881790Diekman EF, Visser G, Schmitz JP, Nievelstein RA, de Sain-van der Velden M, Wardrop M, Van der Pol WL, Houten SM, van Riel NA, Takken T, Jeneson JA. Altered Energetics of Exercise Explain Risk of Rhabdomyolysis in Very Long-Chain Acyl-CoA Dehydrogenase Deficiency. PLoS One. 2016 Feb 16;11(2):e0147818. doi: 10.1371/journal.pone.0147818. eCollection 2016.
- Background: PubMed 27106217Sentner CP, Hoogeveen IJ, Weinstein DA, Santer R, Murphy E, McKiernan PJ, Steuerwald U, Beauchamp NJ, Taybert J, Laforet P, Petit FM, Hubert A, Labrune P, Smit GPA, Derks TGJ. Glycogen storage disease type III: diagnosis, genotype, management, clinical course and outcome. J Inherit Metab Dis. 2016 Sep;39(5):697-704. doi: 10.1007/s10545-016-9932-2. Epub 2016 Apr 22.
- Background: PubMed 26437929Verbeek RJ, Sentner CP, Smit GP, Maurits NM, Derks TG, van der Hoeven JH, Sival DA. Muscle Ultrasound in Patients with Glycogen Storage Disease Types I and III. Ultrasound Med Biol. 2016 Jan;42(1):133-42. doi: 10.1016/j.ultrasmedbio.2015.08.013. Epub 2015 Oct 3.
- Background: PubMed 25832663Preisler N, Laforet P, Madsen KL, Prahm KP, Hedermann G, Vissing CR, Galbo H, Vissing J. Skeletal muscle metabolism is impaired during exercise in glycogen storage disease type III. Neurology. 2015 Apr 28;84(17):1767-71. doi: 10.1212/WNL.0000000000001518. Epub 2015 Apr 1.
- Derived from this study: PubMed 33448466Hoogeveen IJ, de Boer F, Boonstra WF, van der Schaaf CJ, Steuerwald U, Sibeijn-Kuiper AJ, Vegter RJK, van der Hoeven JH, Heiner-Fokkema MR, Clarke KC, Cox PJ, Derks TGJ, Jeneson JAL. Effects of acute nutritional ketosis during exercise in adults with glycogen storage disease type IIIa are phenotype-specific: An investigator-initiated, randomized, crossover study. J Inherit Metab Dis. 2021 Jan;44(1):226-239. doi: 10.1002/jimd.12302. Epub 2020 Sep 7.
- Individual participant dataSharing planned: Undecided
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.
T.G.J. Derks, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Glycogen Storage Disease IIIA, run by University Medical Center Groningen at 1 site in Netherlands.
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 8 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 1 May 2018. 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 Netherlands. 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?
Description of in vivo energy and proton balance during exercise in MR scanner with and without ketone ester drink: steady-state intramuscular levels of glycogen, Pi, PCr and pH and kinetic rate constant of metabolic recovery. (time frame: 10 minutes; during in-magnet exercise test of session II and III.). 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 NCT03011203, which also lists 6 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 1 May 2018.