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Clinical Trials/NCT04021732
NCT04021732
Completed
Not Applicable

Effects of Exercise on Metabolic Parameters in Treated Patients With Classical Homocystinuria: a Research Project on a Small Sample Size, Compared to Healthy Controls.

University of Lausanne2 sites in 1 country12 target enrollmentJuly 1, 2019
ConditionsHomocystinuria

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Homocystinuria
Sponsor
University of Lausanne
Enrollment
12
Locations
2
Primary Endpoint
Plasma homocysteine concentration
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christel Tran

Associate physician

University of Lausanne

Eligibility Criteria

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)

Study Sites (2)

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