Effects of Exercise on Metabolic Parameters in Treated Patients With Classical Homocystinuria: a Research Project on a Small Sample Size, Compared to Healthy Controls.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Lausanne
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Plasma homocysteine concentration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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)
Outcomes
Primary Outcomes
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 Outcomes
- Dietary parameters(During 3 days before and on the day of the exercise (day 1))
- Indirect calorimetry(-90 minutes before exercise to the end of exercise (+30 minutes))
- Plasma amino acid profile(-90 minutes before exercise to 24hours after a 30 minute exercise)
- Plasma Insulin concentration(-90 minutes before exercise to 24 hours after a 30 minute exercise)
- Plasma lactate concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
- Plasma glucagon concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
- Plasma free fatty acids concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
- Plasma ketone bodies concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
- Plasma cortisol concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
- Blood pressure(-90 min before exercise to 24 hours after a 30 minute exercise)
Investigators
Christel Tran
Associate physician
University of Lausanne