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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04021732
Other study ID # 2018-02400
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 1, 2020

Study information

Verified date February 2021
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 1, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Département de physiologie Lausanne Vaud
Switzerland Lausanne University Hospitals Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma homocysteine concentration Change in homocysteine concentration after a 30 minute exercise at fixed wattage -90 minutes before exercise to 24 hours after a 30 minute exercise
Secondary Dietary parameters self-reporting daily food diary During 3 days before and on the day of the exercise (day 1)
Secondary Indirect calorimetry Energy expenditure -90 minutes before exercise to the end of exercise (+30 minutes)
Secondary Plasma amino acid profile Change in amino acid profile after a 30 minute exercise at fixed wattage -90 minutes before exercise to 24hours after a 30 minute exercise
Secondary Plasma Insulin concentration Change in insulin concentration after a 30 minute exercise at fixed wattage -90 minutes before exercise to 24 hours after a 30 minute exercise
Secondary Plasma lactate concentration Change in lactate concentration after a 30 minute exercise at fixed wattage -90 minute before exercise to 24 hours after a 30 minute exercise
Secondary Plasma glucagon concentration Change in glucagon concentration after a 30 minute exercise at fixed wattage -90 minute before exercise to 24 hours after a 30 minute exercise
Secondary Plasma free fatty acids concentration Change in free fatty acids concentration after a 30 minute exercise at fixed wattage -90 minute before exercise to 24 hours after a 30 minute exercise
Secondary Plasma ketone bodies concentration Change in ketone bodies concentration after a 30 minute exercise at fixed wattage -90 minute before exercise to 24 hours after a 30 minute exercise
Secondary Plasma cortisol concentration Change in cortisol concentration after a 30 minute exercise at fixed wattage -90 minute before exercise to 24 hours after a 30 minute exercise
Secondary Blood pressure Change in blood pressure after a 30 minute exercise at fixed wattage -90 min before exercise to 24 hours after a 30 minute exercise
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