Metabolism, Inborn ErrorsNCT02635269
Fat and Sugar Metabolism During Exercise in Patients With Metabolic Myopathy
A study testing Sugar in people with Metabolism, Inborn Errors and Lipid Metabolism, Inborn Errors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study aims to characterize the pathophysiological mechanisms of 21 different metabolic myopathies. The study will focus on exercise capacity and the metabolic derangement during exercise. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Inborn Errors, Lipid Metabolism, Inborn Errors, Carbohydrate Metabolism, Inborn Errors
- What is being tested?
- Sugar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Dec 2020
- 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women with genetically and/or biochemically verified LCHAD Deficiency
- Healthy controls needs to be healthy to be included, evaluated by the investigator.
Who cannot join
- Competing conditions at risk of compromising the results of the study.
- Pregnancy or breastfeeding
- Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise.
- Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
- Veins that are too difficult to puncture for blood sampling or insertion of intravenous catheters, evaluated by the investigator
- Moderate to severe muscle weakness, that prevents the subject completing 10 minutes of cycle-ergometry exercise at 60-70 % of VO2peak, evaluated by the investigator.
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- Participation in other trials that may interfere with the results.
- Intake of medications that may interfere with the results or may compromise exercise performance, as evaluated by the investigators.
- Donation of blood within 30 days prior to conduction of the tests on test day 1.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to characterize the pathophysiological mechanisms of 21 different metabolic myopathies. The study will focus on exercise capacity and the metabolic derangement during exercise.
Read the detailed description
Patients will be compared to a group of matched healthy control subjects (matched for age, gender, physical activity level and BMI) for comparison of the primary and secondary outcome measures.
Methods:
Each subject will go through 3 test days.
Test day 1:
- International Physical Activity Questionnaire (IPAQ). The results will be used to match the patients to control subjects.
- DEXA-scan. This is used to estimate the volume of distribution for stable isotope tracers.
- Maximal oxidative capacity test (max-test). On a cycle ergometer, subjects will exercise for approximately 15 minutes with increasing resistance until exhaustion. The peak oxidative and workload capacities will be compared to the healthy controls and will be used to find the workload that corresponds to 55-65 % of VO2max used in the following exercise tests.
- Blood samples. Samples will be drawn before exercise and at exhaustion and will be analyzed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
Test day 2:
•Long exercise test #1. The purpose of this test is to measure the total fat and sugar oxidation rates during exercise by using stable isotope tracers.
Subjects arrive at the laboratory after 3-9 hours of fasting. One IV-catheter is inserted in the cubital vein in one arm and another in a peripheral vein in the other hand. The stable isotope tracers will be given in the cubital vein as a constant infusion of solutions of:
- [U-13C]-palmitate (0.0026 mg x kg-1 x min-1, after a priming bolus of 0.085 mg x kg-1 NaH13CO3)
- [1,1,2,3,3-2H5]-glycerol (0.0049 mg x kg-1 x min-1 )
- [6.6-2H2]-glucose (0.0728 mg x kg-1 x min-1 ) For two hours the subjects rests while receiving the infusions until the tracers have distributed in the body and reached a steady state. After the rest, the subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 55-65% of VO2max.
The heart rate is continuously measured during exercise, and every other minute the subject evaluates his/her degree of exertion (Rate of Perceived Exertion, RPE) on a Borg scale.
•Blood and breath samples From 20 minutes before exercise and every ten minutes until the end of exercise, blood samples are drawn and samples of the expired breath are collected.The breath is analysed for 13CO2 -enrichment. The blood is analysed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
Test day 3:
•Long exercise test #2. The purpose of this test is to investigate exercise capacity and performance measured as HR, VO2 and RPE during prolonged exercise. To mimic the conditions for the working muscles in healthy persons who have an intact metabolism, the patients are given an infusion of a 10% glucose solution to maintain the blood sugar while exercising.
Subjects arrive at the laboratory after 3-9 hours fasting. After 2 hours of rest, the subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 60-65% of VO2max, like they did on test day 2. This time the subjects are not given stable isotope tracers. 10 minutes before exercising, the subjects are given a bolus of glucose solution 0.2 g/kg in a cubital vein catheter and a constant infusion of 10% glucose solution is started (100ml/h). The infusion continues throughout the exercise period.
Assessments of heart rate, Rate of Perceived Exertion and blood sampling follow the same protocol as on test day 1, except no breath samples are taken and no analyses of stable isotopes are made, since the tracers are not used on test day 3.
- Blood samples. From 20 minutes before exercise and every ten minutes until the end of exercise, blood samples are drawn. The blood is analysed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
- Muscle Biopsy At the end of test day 1 the investigators will perform a voluntary muscle biopsy.
Statistical Methods:
The investigators will use a paired t-test, two-tailed testing (or the corresponding non-parametric test, if the assumption of normality is not met). A p-value of < 0.05 will be considered significant. Results will be reported with Confidence Intervals of the difference in means. SigmaPlot version 11.0 (or a similar statistical program) will be used for statistical analysis.
No interim analyses will be made during the 4 days trial period. In the case, that a patient withdraws/is withdrawn, the obtained data from the completed tests will be included in the analyses. Raw data that is clearly and indisputably a result of an error in measurement will not be included (evaluated by the investigator). Missing or lost data will if possible be reassessed.
- Conditions
- Metabolism, Inborn Errors, Lipid Metabolism, Inborn Errors, Carbohydrate Metabolism, Inborn Errors, Long-Chain 3-Hydroxyacyl-CoA Dehydrogenase Deficiency, Glycogenin-1 Deficiency (Glycogen Storage Disease Type XV), Carnitine Palmitoyl Transferase 2 Deficiency
- Being tested
- Sugar
- Keywords
- Ergometry, Stable isotope tracers
- Medical subject headings
- Metabolism, Inborn Errors, Lipid Metabolism, Inborn Errors, Carbohydrate Metabolism, Inborn Errors, Trifunctional Protein Deficiency With Myopathy And Neuropathy, Carnitine palmitoyl transferase 2 deficiency, VLCAD deficiency, Medium chain acyl CoA dehydrogenase deficiency, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarOther
Also called 10 % glucose infusion
10 minutes before exercising, the subjects are given a bolus of glucose solution 0.2 g/kg in a cubital vein catheter and a constant infusion of 10% glucose solution is started (100ml/h). The infusion continues throughout the exercise period.
| Study group | Role | What they receive |
|---|---|---|
| Sugar | Experimental | The subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 60-65% of VO2max. Receives: Other: Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
Measured using stable isotope technique ([U-13C]-palmitate, [1,1,2,3,3-2H5]-glycerol and [6.6-2H2]-glucose ) and indirect calorimetry.
Measured: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation
Secondary outcomes (7)
Maximal oxidative capacity (mL*kg-1*minutes-1)
Oxidative capacity is measured continuously during a maximum exercise test on the first day of the trial. The test lasts about 15 minutes (when the participant is fully exhausted). The maximal oxidative capacity is the peak measure during the test.
Measured: Day 1 of participation
Endurance measured as minutes:seconds
During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation. The test will last for 1 hour or until exhaustion. Endurance will be defined as the total exercise duration.
Measured: Day 2 and 4 of participation
Heart rate (HR) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in beats per minute.
During 1 hour cycling at 55-65% of VO2max the heart rate is measured every 2 minuts.
Measured: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Oxygen consumption rate (VO2) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in mL.
During 1 hour cycling at 55-65% of VO2max the oxygen consumption rate is continuously measured.
Measured: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Self-evaluated exertion (Rate of Perceived Exertion (RPE)) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured using a Borg-scale (6-20).
During 1 hour cycling at 55-65% of VO2max the participant is asked to rate their exertion every 2 minutes.
Measured: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Maximal workload capacity. Measured in watt
The participant will be cycling at incremental workload until exhaustion. The test lasts about 15 minutes (when the participant is fully exhausted). The maximal workload is the peak measure at the end of the test.
Measured: Day 1 of participation
Total glucose oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
Measured using stable isotope technique ([U-13C]-palmitate, [1,1,2,3,3-2H5]-glycerol and [6.6-2H2]-glucose ) and indirect calorimetry.
Measured: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolism, Inborn ErrorsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Lindhardt Madsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Karen L Madsen, MD, Principal investigator, Neuromuscular Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635269
- Sponsor's protocol ID
- Metabolic Myopathy
- Other IDs
- H-15015150
- Status last verified
- Oct 2019
- First submitted
- 9 Dec 2015
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oldfors A, DiMauro S. New insights in the field of muscle glycogenoses. Curr Opin Neurol. 2013 Oct;26(5):544-53. doi: 10.1097/WCO.0b013e328364dbdc.
PubMed 23995275Liang WC, Nishino I. State of the art in muscle lipid diseases. Acta Myol. 2010 Oct;29(2):351-6.
PubMed 21314018Orngreen MC, Duno M, Ejstrup R, Christensen E, Schwartz M, Sacchetti M, Vissing J. Fuel utilization in subjects with carnitine palmitoyltransferase 2 gene mutations. Ann Neurol. 2005 Jan;57(1):60-6. doi: 10.1002/ana.20320.
PubMed 15622536Raaschou-Pedersen D, Madsen KL, Stemmerik MG, Eisum AV, Straub V, Vissing J. Fat oxidation is impaired during exercise in lipin-1 deficiency. Neurology. 2019 Oct 8;93(15):e1433-e1438. doi: 10.1212/WNL.0000000000008240. Epub 2019 Sep 6.
PubMed 31492716Madsen KL, Stemmerik MG, Buch AE, Poulsen NS, Lund AM, Vissing J. Impaired Fat Oxidation During Exercise in Long-Chain Acyl-CoA Dehydrogenase Deficiency Patients and Effect of IV-Glucose. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3610-3613. doi: 10.1210/jc.2019-00453.
PubMed 30990523
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat and Sugar Metabolism During Exercise in Patients With Metabolic Myopathy
- ClinicalTrials.gov ID
- NCT02635269
- Acronym / sponsor ID
- Metabolic Myopathy
- Conditions
- Metabolism, Inborn Errors, Lipid Metabolism, Inborn Errors, Carbohydrate Metabolism, Inborn Errors, Long-Chain 3-Hydroxyacyl-CoA Dehydrogenase Deficiency, Glycogenin-1 Deficiency (Glycogen Storage Disease Type XV), Carnitine Palmitoyl Transferase 2 Deficiency
- Keywords
- Ergometry, Stable isotope tracers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Dec 2015 (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.
This study aims to characterize the pathophysiological mechanisms of 21 different metabolic myopathies. The study will focus on exercise capacity and the metabolic derangement during exercise.
Detailed description
Patients will be compared to a group of matched healthy control subjects (matched for age, gender, physical activity level and BMI) for comparison of the primary and secondary outcome measures.
Methods:
Each subject will go through 3 test days.
Test day 1:
- International Physical Activity Questionnaire (IPAQ). The results will be used to match the patients to control subjects.
- DEXA-scan. This is used to estimate the volume of distribution for stable isotope tracers.
- Maximal oxidative capacity test (max-test). On a cycle ergometer, subjects will exercise for approximately 15 minutes with increasing resistance until exhaustion. The peak oxidative and workload capacities will be compared to the healthy controls and will be used to find the workload that corresponds to 55-65 % of VO2max used in the following exercise tests.
- Blood samples. Samples will be drawn before exercise and at exhaustion and will be analyzed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
Test day 2:
•Long exercise test #1. The purpose of this test is to measure the total fat and sugar oxidation rates during exercise by using stable isotope tracers.
Subjects arrive at the laboratory after 3-9 hours of fasting. One IV-catheter is inserted in the cubital vein in one arm and another in a peripheral vein in the other hand. The stable isotope tracers will be given in the cubital vein as a constant infusion of solutions of:
- [U-13C]-palmitate (0.0026 mg x kg-1 x min-1, after a priming bolus of 0.085 mg x kg-1 NaH13CO3)
- [1,1,2,3,3-2H5]-glycerol (0.0049 mg x kg-1 x min-1 )
- [6.6-2H2]-glucose (0.0728 mg x kg-1 x min-1 ) For two hours the subjects rests while receiving the infusions until the tracers have distributed in the body and reached a steady state. After the rest, the subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 55-65% of VO2max.
The heart rate is continuously measured during exercise, and every other minute the subject evaluates his/her degree of exertion (Rate of Perceived Exertion, RPE) on a Borg scale.
•Blood and breath samples From 20 minutes before exercise and every ten minutes until the end of exercise, blood samples are drawn and samples of the expired breath are collected.The breath is analysed for 13CO2 -enrichment. The blood is analysed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
Test day 3:
•Long exercise test #2. The purpose of this test is to investigate exercise capacity and performance measured as HR, VO2 and RPE during prolonged exercise. To mimic the conditions for the working muscles in healthy persons who have an intact metabolism, the patients are given an infusion of a 10% glucose solution to maintain the blood sugar while exercising.
Subjects arrive at the laboratory after 3-9 hours fasting. After 2 hours of rest, the subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 60-65% of VO2max, like they did on test day 2. This time the subjects are not given stable isotope tracers. 10 minutes before exercising, the subjects are given a bolus of glucose solution 0.2 g/kg in a cubital vein catheter and a constant infusion of 10% glucose solution is started (100ml/h). The infusion continues throughout the exercise period.
Assessments of heart rate, Rate of Perceived Exertion and blood sampling follow the same protocol as on test day 1, except no breath samples are taken and no analyses of stable isotopes are made, since the tracers are not used on test day 3.
- Blood samples. From 20 minutes before exercise and every ten minutes until the end of exercise, blood samples are drawn. The blood is analysed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
- Muscle Biopsy At the end of test day 1 the investigators will perform a voluntary muscle biopsy.
Statistical Methods:
The investigators will use a paired t-test, two-tailed testing (or the corresponding non-parametric test, if the assumption of normality is not met). A p-value of < 0.05 will be considered significant. Results will be reported with Confidence Intervals of the difference in means. SigmaPlot version 11.0 (or a similar statistical program) will be used for statistical analysis.
No interim analyses will be made during the 4 days trial period. In the case, that a patient withdraws/is withdrawn, the obtained data from the completed tests will be included in the analyses. Raw data that is clearly and indisputably a result of an error in measurement will not be included (evaluated by the investigator). Missing or lost data will if possible be reassessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sugar | Experimental | Other: SugarThe subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 60-65% of VO2max. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women with genetically and/or biochemically verified LCHAD Deficiency
- Healthy controls needs to be healthy to be included, evaluated by the investigator.
Key exclusion criteria (9 listed)
- Competing conditions at risk of compromising the results of the study.
- Pregnancy or breastfeeding
- Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise.
- Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
- Veins that are too difficult to puncture for blood sampling or insertion of intravenous catheters, evaluated by the investigator
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 |
|---|---|---|
| SugarAlso: 10 % glucose infusion10 minutes before exercising, the subjects are given a bolus of glucose solution 0.2 g/kg in a cubital vein catheter and a constant infusion of 10% glucose solution is started (100ml/h). The infusion continues throughout the exercise period. | Other | Sugar |
Primary outcome
Total fat oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
Time frame: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation
Measured using stable isotope technique ([U-13C]-palmitate, [1,1,2,3,3-2H5]-glycerol and [6.6-2H2]-glucose ) and indirect calorimetry.
7 secondary outcomes
Maximal oxidative capacity (mL*kg-1*minutes-1)
Time frame: Day 1 of participation
Endurance measured as minutes:seconds
Time frame: Day 2 and 4 of participation
Heart rate (HR) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in beats per minute.
Time frame: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Oxygen consumption rate (VO2) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in mL.
Time frame: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Self-evaluated exertion (Rate of Perceived Exertion (RPE)) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured using a Borg-scale (6-20).
Time frame: During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.
Maximal workload capacity. Measured in watt
Time frame: Day 1 of participation
Total glucose oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
Time frame: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 23995275Oldfors A, DiMauro S. New insights in the field of muscle glycogenoses. Curr Opin Neurol. 2013 Oct;26(5):544-53. doi: 10.1097/WCO.0b013e328364dbdc.
- Background: PubMed 21314018Liang WC, Nishino I. State of the art in muscle lipid diseases. Acta Myol. 2010 Oct;29(2):351-6.
- Background: PubMed 15622536Orngreen MC, Duno M, Ejstrup R, Christensen E, Schwartz M, Sacchetti M, Vissing J. Fuel utilization in subjects with carnitine palmitoyltransferase 2 gene mutations. Ann Neurol. 2005 Jan;57(1):60-6. doi: 10.1002/ana.20320.
- Derived from this study: PubMed 31492716Raaschou-Pedersen D, Madsen KL, Stemmerik MG, Eisum AV, Straub V, Vissing J. Fat oxidation is impaired during exercise in lipin-1 deficiency. Neurology. 2019 Oct 8;93(15):e1433-e1438. doi: 10.1212/WNL.0000000000008240. Epub 2019 Sep 6.
- Derived from this study: PubMed 30990523Madsen KL, Stemmerik MG, Buch AE, Poulsen NS, Lund AM, Vissing J. Impaired Fat Oxidation During Exercise in Long-Chain Acyl-CoA Dehydrogenase Deficiency Patients and Effect of IV-Glucose. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3610-3613. doi: 10.1210/jc.2019-00453.
- Individual participant dataSharing planned: No
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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.
Karen L Madsen, MD principal investigator
Neuromuscular Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar in people with Metabolism, Inborn Errors and Lipid Metabolism, Inborn Errors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
Total fat oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute. (time frame: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation). 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 NCT02635269, which also lists 5 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 16 Oct 2019.