NCT02965963

Brief Summary

The purpose of this study is to examine the effect of dopamine infusion and dopamine-2 receptor blockade on pulmonary capillary blood volume, diffusion, and the hemodynamic variables of pulmonary artery pressure, cardiac output, and pulmonary vascular resistance during exercise. Secondarily, this study will examine the effect of dopamine infusion and dopamine-2 receptor blockade on exercise tolerance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

8.5 years

First QC Date

November 10, 2016

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Pulmonary Capillary Blood Volume

    Roughton and Forster's Three FIO2 DLCO Method at Rest, 60% of Vo2max, and 85% of Vo2max

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

  • Diffusing Capacity for Carbon Monoxide

    Roughton and Forster's Three FIO2 DLCO Method at Rest, 60% of Vo2max, and 85% of Vo2max

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

  • Pulmonary Artery Systolic Pressure

    Non-invasive estimation using Doppler echocardiography at Rest \& 60% of Vo2max

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

  • Cardiac Output

    Non-invasive estimation using trans-thoracic impedance cardiography at rest, 60% of Vo2max, and 85% of Vo2max

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

  • Pulmonary Vascular Resistance

    Calculation

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

Secondary Outcomes (2)

  • Exercise Tolerance

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

  • Exertional Dyspnea

    Dopamine (Day 1), Metoclopramide (Day 2), Placebos (Day 3) *order randomized

Study Arms (3)

Dopamine

EXPERIMENTAL

Dependent variables measured with intravenous low dose dopamine infusion at rest, 60%, and 85% of VO2max

Drug: DopamineOther: RestOther: Exercise - 60%Other: Exercise - 85%

Metoclopramide

EXPERIMENTAL

Dependent variables measured with oral metoclopramide ingestion at rest, 60%, and 85% of VO2max

Drug: MetoclopramideOther: RestOther: Exercise - 60%Other: Exercise - 85%

Placebos

EXPERIMENTAL

Dependent variables measured with orally ingested placebo pill and intravenous saline at rest, 60%, and 85% of VO2max

Drug: PlacebosOther: RestOther: Exercise - 60%Other: Exercise - 85%

Interventions

Dopamine
Metoclopramide
Placebos
RestOTHER
DopamineMetoclopramidePlacebos

60% of VO2max

DopamineMetoclopramidePlacebos

85% of VO2max

DopamineMetoclopramidePlacebos

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active (exercising \>2 times per week)
  • BMI \< 30kg/m2
  • No known cardiac or pulmonary disease

You may not qualify if:

  • Known cardiac or pulmonary diseases / abnormalities
  • Use of medications that could interfere with dopaminergic pathways (i.e. dopaminergic agonists / antagonists, alcohol, central nervous system depressants, and serotonergic drugs)
  • BMI \> 30kg/m2
  • Female subjects must not be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Physiology Research Laboratory

Edmonton, Alberta, T6G 2J1, Canada

Location

Related Publications (4)

  • Tedjasaputra V, Bryan TL, van Diepen S, Moore LE, Bouwsema MM, Welsh RC, Petersen SR, Stickland MK. Dopamine receptor blockade improves pulmonary gas exchange but decreases exercise performance in healthy humans. J Physiol. 2015 Jul 15;593(14):3147-57. doi: 10.1113/JP270238. Epub 2015 Jun 8.

    PMID: 25952760BACKGROUND
  • ROUGHTON FJ, FORSTER RE. Relative importance of diffusion and chemical reaction rates in determining rate of exchange of gases in the human lung, with special reference to true diffusing capacity of pulmonary membrane and volume of blood in the lung capillaries. J Appl Physiol. 1957 Sep;11(2):290-302. doi: 10.1152/jappl.1957.11.2.290. No abstract available.

    PMID: 13475180BACKGROUND
  • Argiento P, Chesler N, Mule M, D'Alto M, Bossone E, Unger P, Naeije R. Exercise stress echocardiography for the study of the pulmonary circulation. Eur Respir J. 2010 Jun;35(6):1273-8. doi: 10.1183/09031936.00076009. Epub 2009 Nov 19.

    PMID: 19926746BACKGROUND
  • Bryan TL, van Diepen S, Bhutani M, Shanks M, Welsh RC, Stickland MK. The effects of dobutamine and dopamine on intrapulmonary shunt and gas exchange in healthy humans. J Appl Physiol (1985). 2012 Aug 15;113(4):541-8. doi: 10.1152/japplphysiol.00404.2012. Epub 2012 Jun 14.

    PMID: 22700799BACKGROUND

MeSH Terms

Interventions

DopamineMetoclopramideRE1-silencing transcription factor

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsPhenyl Ethers

Study Officials

  • Michael K Stickland, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 17, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations