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出境医 / 临床实验 / Effects of Exercise on Metabolic Parameters in Classical Homocystinuria
Effects of Exercise on Metabolic Parameters in Classical Homocystinuria
Study Description
Brief Summary:
The aim of this research project is to compare the effect of an aerobic exercise session in two different populations. Sampling biological material and collecting health-related personal data entails minimal risks and burdens. Participants will be asked to perform 30 minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a moderate intensity for a sedentary population.
| Condition or disease |
|---|
| Homocystinuria |
Detailed Description:
Background Among genetic causes of hyperhomocysteinemia, classical homocystinuria, manifest not only with vascular diseases but also with neurological symptoms. This is related to the higher homocysteine concentration of up to 150-300 μmol/l without treatment. Recently, some articles have shown that mild and temporary hyperhomocysteinemia may follow exercise in a healthy population. Investigators hypothesized that increase in homocysteine may be of greater importance in patients with classical homocystinuria where cystathionine beta-synthase deficiency prevents homocysteine metabolism.
Objective To investigate the effect of an aerobic exercise in patients with classical homocystinuria on metabolic parameters compared to healthy controls.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 12 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Effects of Exercise on Metabolic Parameters in Treated Patients With Classical Homocystinuria: a Research Project on a Small Sample Size, Compared to Healthy Controls. |
| Actual Study Start Date : | July 1, 2019 |
| Actual Primary Completion Date : | April 30, 2020 |
| Actual Study Completion Date : | December 1, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Plasma homocysteine concentration [ Time Frame: -90 minutes before exercise to 24 hours after a 30 minute exercise ]Change in homocysteine concentration after a 30 minute exercise at fixed wattage
Secondary Outcome Measures :
- Dietary parameters [ Time Frame: During 3 days before and on the day of the exercise (day 1) ]self-reporting daily food diary
- Indirect calorimetry [ Time Frame: -90 minutes before exercise to the end of exercise (+30 minutes) ]Energy expenditure
- Plasma amino acid profile [ Time Frame: -90 minutes before exercise to 24hours after a 30 minute exercise ]Change in amino acid profile after a 30 minute exercise at fixed wattage
- Plasma Insulin concentration [ Time Frame: -90 minutes before exercise to 24 hours after a 30 minute exercise ]Change in insulin concentration after a 30 minute exercise at fixed wattage
- Plasma lactate concentration [ Time Frame: -90 minute before exercise to 24 hours after a 30 minute exercise ]Change in lactate concentration after a 30 minute exercise at fixed wattage
- Plasma glucagon concentration [ Time Frame: -90 minute before exercise to 24 hours after a 30 minute exercise ]Change in glucagon concentration after a 30 minute exercise at fixed wattage
- Plasma free fatty acids concentration [ Time Frame: -90 minute before exercise to 24 hours after a 30 minute exercise ]Change in free fatty acids concentration after a 30 minute exercise at fixed wattage
- Plasma ketone bodies concentration [ Time Frame: -90 minute before exercise to 24 hours after a 30 minute exercise ]Change in ketone bodies concentration after a 30 minute exercise at fixed wattage
- Plasma cortisol concentration [ Time Frame: -90 minute before exercise to 24 hours after a 30 minute exercise ]Change in cortisol concentration after a 30 minute exercise at fixed wattage
- Blood pressure [ Time Frame: -90 min before exercise to 24 hours after a 30 minute exercise ]Change in blood pressure after a 30 minute exercise at fixed wattage
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Endocrinology Clinic
Criteria
Inclusion Criteria for subjects:
- Informed consent as documented by signature
- Confirmed biallelic mutation of cystathionine beta-synthase deficiency gene (homozygous or compound heterozygous) in an accredited Laboratory
- Continuation of their regular treatment under same dose (e.g. vitamin B6, B9 and B12, betaine) as prior to the study inclusion
Inclusion Criteria for controls:
- Healthy
Exclusion Criteria:
- Any clinically instable concomitant disease
- Individuals with acute cardiac events, syncope, rhythm disturbances or unstable hypertension in the past 6 months
- Individuals with vitamins B9 or B12 deficiencies
- Homocysteine > 100 µmol/l (for subjects)
- Homocysteine > 20 µmol/l (for controls)
Contacts and Locations
Locations
| Switzerland | |
| Département de physiologie | |
| Lausanne, Vaud, Switzerland, 1005 | |
| Lausanne University Hospitals | |
| Lausanne, Vaud, Switzerland, 1011 | |
Sponsors and Collaborators
University of Lausanne
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 9, 2019 | ||||
| First Posted Date | July 16, 2019 | ||||
| Last Update Posted Date | March 30, 2021 | ||||
| Actual Study Start Date | July 1, 2019 | ||||
| Actual Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Plasma homocysteine concentration [ Time Frame: -90 minutes before exercise to 24 hours after a 30 minute exercise ] Change in homocysteine concentration after a 30 minute exercise at fixed wattage
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Effects of Exercise on Metabolic Parameters in Classical Homocystinuria | ||||
| Official Title | Effects of Exercise on Metabolic Parameters in Treated Patients With Classical Homocystinuria: a Research Project on a Small Sample Size, Compared to Healthy Controls. | ||||
| Brief Summary | The aim of this research project is to compare the effect of an aerobic exercise session in two different populations. Sampling biological material and collecting health-related personal data entails minimal risks and burdens. Participants will be asked to perform 30 minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a moderate intensity for a sedentary population. | ||||
| Detailed Description |
Background Among genetic causes of hyperhomocysteinemia, classical homocystinuria, manifest not only with vascular diseases but also with neurological symptoms. This is related to the higher homocysteine concentration of up to 150-300 μmol/l without treatment. Recently, some articles have shown that mild and temporary hyperhomocysteinemia may follow exercise in a healthy population. Investigators hypothesized that increase in homocysteine may be of greater importance in patients with classical homocystinuria where cystathionine beta-synthase deficiency prevents homocysteine metabolism. Objective To investigate the effect of an aerobic exercise in patients with classical homocystinuria on metabolic parameters compared to healthy controls. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Endocrinology Clinic | ||||
| Condition | Homocystinuria | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
12 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | December 1, 2020 | ||||
| Actual Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria for subjects:
Inclusion Criteria for controls: - Healthy Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 60 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04021732 | ||||
| Other Study ID Numbers | 2018-02400 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Christel Tran, University of Lausanne | ||||
| Study Sponsor | University of Lausanne | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University of Lausanne | ||||
| Verification Date | February 2021 | ||||
