Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity

NCT ID: NCT03949075

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Angiotensin-Converting Enzyme Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
The present study is double-blinded with regard to ACE genotype and study medication and the blinding is kept until completion of the trial

Study Groups

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Enalapril treatment

Group Type EXPERIMENTAL

Enalapril

Intervention Type DRUG

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

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Enalapril

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 20-50 years
* Healthy

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Nikolai Nordsborg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolai B Nordsborg, phD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Rigat B, Hubert C, Alhenc-Gelas F, Cambien F, Corvol P, Soubrier F. An insertion/deletion polymorphism in the angiotensin I-converting enzyme gene accounting for half the variance of serum enzyme levels. J Clin Invest. 1990 Oct;86(4):1343-6. doi: 10.1172/JCI114844.

Reference Type BACKGROUND
PMID: 1976655 (View on PubMed)

Montgomery HE, Marshall R, Hemingway H, Myerson S, Clarkson P, Dollery C, Hayward M, Holliman DE, Jubb M, World M, Thomas EL, Brynes AE, Saeed N, Barnard M, Bell JD, Prasad K, Rayson M, Talmud PJ, Humphries SE. Human gene for physical performance. Nature. 1998 May 21;393(6682):221-2. doi: 10.1038/30374. No abstract available.

Reference Type BACKGROUND
PMID: 9607758 (View on PubMed)

Sjuretharson T, Bejder J, Breenfeldt Andersen A, Bonne TC, Kyhl K, Thomassen M, Prats J, Oddmarsdottir Gregersen N, Skoradal MB, Weihe P, Nordsborg NB, Mohr M. Robust arm and leg muscle adaptation to training despite ACE inhibition: a randomized placebo-controlled trial. Eur J Appl Physiol. 2023 Feb;123(2):325-337. doi: 10.1007/s00421-022-05072-5. Epub 2022 Oct 22.

Reference Type DERIVED
PMID: 36271942 (View on PubMed)

Other Identifiers

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H-18016341

Identifier Type: -

Identifier Source: org_study_id