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Completed

NCT Number: NCT03949075

Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity

The phenotype based on the insertion/deletion (I/D) polymorphism of the human angiotensin converting enzyme (ACE) gene has been associated with individual training response. Briefly, intervention studies have demonstrated an 11-fold greater training-induced improvement in muscular endurance for ACE I/I homozygotes compared to ACE D/D homozygotes.

Importantly, the ACE I/D polymorphism causes large inter-individual differences in serum ACE activity. Because the ACE D/D genotype is characterized by high plasma ACE activity and potentially blunted endurance exercise training response, it appears likely that ACE inhibitors (ACEi) have the potential to improve the outcome of exercise training for ACE D/D homozygotes.

Thus, in the present study the investigators apply a randomized double-blind placebo-controlled longitudinal design to investigate whether pharmacological inhibition of ACE activity can amplify the exercise training response in healthy humans carrying either the ACE D/D or ACE I/I genotype.

The study hypothesis is that inhibition of ACE activity in healthy humans with the ACE D/D genotype will amplify the health beneficial effects of exercise training while this is not the case in ACE I/I homozygotes.

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Key information

Conditions

Exercise Angiotensin-Converting Enzyme Inhibitors Behavior Motor Activity

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 20-50 years
  • Healthy

Exclusion criteria

-

Treatment and study plan

Enalapril

Drug

Participants will be assigned to daily administration of ACE inhibitors (Initially 5 mg Corodil® 'Enalapril' daily followed by up to 20 mg daily dependent on the blood pressure response) combined with an 8-week training period.

Placebo

Drug

Participants will be assigned to daily administration of placebo (5-20 mg CaCO3) combined with an 8-week training period.

Primary outcomes

  1. Maximal systemic oxygen uptake

    Time frame: 20 minutes

    Training-induced changes in maximal systemic oxygen uptake (L/min) is evaluated with an incremental maximal cycle protocol on a cycle ergometer

  2. Skeletal muscle endurance

    Time frame: 5 minutes

    Training-induced changes in muscle endurance evaluated as changes in duration (sec) of a repetitive elbow-flexion exercise

Secondary outcomes

  1. Blood volume

    Time frame: 20 minutes

    Training-induced changes in total blood volume (mL) is measured using the Carbon-monoxide rebreathing method.

  2. Endurance performance

    Time frame: 15 minutes

    Training-induced changes in endurance performance is determined by a 2000 meter time trial on an indoor rowing ergometer

  3. Skeletal muscle oxidative capacity

    Time frame: 60 minutes

    Training-induced changes in muscle oxidative capacity is evaluated as maximal citrate synthase and 3- hydroxy-acetylCoa-dehydrogenase activity (µmol/g/min)

  4. Mitochondrial biogenesis

    Time frame: 60 minutes

    Expression of complex I-V will be analyzed in order to evaluate if the applied training induced mitochondrial biogenesis.

  5. Mean arterial pressure (MAP)

    Time frame: 10 minutes

    Training-induced changes in resting MAP (mmHg) will be estimated using this formula: MAP = diastolic pressure + 1/3 (systolic pressure - diastolic pressure)

  6. Steady-state systemic oxygen uptake

    Time frame: 10 minutes

    Training-induced changes in steady-state systemic oxygen uptake (mL/min) is determined by indirect calorimetry during a submaximal cycle protocol on a cycle ergometer

  7. Muscle strength

    Time frame: 1 minute

    Training-induced changes in muscle strength (kg) is measured using a handgrip dynamometer

  8. Fat mass

    Time frame: 20 minutes

    Training-induced changes in fat mass (kg) is determined by dual-energy x-ray absorptiometry (DXA)-scan

  9. Fat free mass

    Time frame: 20 minutes

    Training-induced changes in fat free mass (kg) is determined by DXA-scan

  10. Body fat percentage

    Time frame: 20 minutes

    Training-induced changes in body fat percentage (%) is determined by DXA-scan

  11. Left ventricular (LV) mass

    Time frame: 45 minutes

    Training-induced changes in LV mass (g) is determined by cardiac magnetic resonance imaging (cMRI)

  12. LV end-diastolic volume

    Time frame: 45 minutes

    Training-induced changes in LV end-diastolic volume (mL) is determined by cMRI

  13. LV mean wall thickness

    Time frame: 45 minutes

    Training-induced changes in LV mean wall thickness (cm) is determined by cMRI

  14. LV stroke volume

    Time frame: 45 minutes

    Training-induced changes in LV stroke volume (mL) is determined by cMRI

  15. LV ejection fraction

    Time frame: 45 minutes

    LV stroke volume (mL) and LV end-diastolic volume (mL) will be used to measure training-induced changes in LV ejection fraction (%)

Other outcomes

  1. ACE activity

    Time frame: 10 minutes

    Obtained blood samples will be analyzed for ACE activity

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 14, 2019
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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