Histamine as a Molecular Transducer of Adaptation to Exercise

Sponsor

University of Oregon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05206227

Collaborator

(none)

Enrollment

Location

Arm

56.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is investigating the presence of a soluble factor released from exercising skeletal muscle that induces mast cell degranulation.

Condition or Disease	Intervention/Treatment	Phase
Postexercise Hypotension	Behavioral: Exercise	N/A

Detailed Description

Exercise promotes and maintains healthy cardiovascular, musculoskeletal, and metabolic function, but the signals and mechanisms which transduce these effects are poorly understood. Histamine plays a role in some of the positive benefits of exercise. The goal of this study is to determine the factors that regulate exercise's effects on endothelial and vascular function, with a focus on histamine released from mast cells in skeletal muscle. Young, sedentary participants will perform a peak exercise test, then participate in a single one-day experiment during which the investigators will insert an intravenous catheter in an arm vein and microdialysis probes in the leg, collect dialysate from the microdialysis probe and blood from the vein, record noninvasive measures, and have the participants perform exercise with the leg with the probes in it.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Histamine as a Molecular Transducer of Adaptation to Exercise

Actual Study Start Date :

Jul 28, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise	Behavioral: Exercise Subjects will perform one-legged knee extension exercise while seated on a purpose-built ergometer. Subjects will exercise for 60 minutes, which includes 5-minute warm-up at 30% of peak power and 55 minutes at 60% of peak power.

Arm

Intervention/Treatment

Experimental: Exercise

Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise

Behavioral: Exercise

Subjects will perform one-legged knee extension exercise while seated on a purpose-built ergometer. Subjects will exercise for 60 minutes, which includes 5-minute warm-up at 30% of peak power and 55 minutes at 60% of peak power.

Outcome Measures

Primary Outcome Measures

Percentage of mast cell degranulation [One hour]
Beta-hexaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18 -40

Exclusion Criteria:

Systolic ≥ 120
Diastolic ≥ 80
Body mass index (BMI) ˃ 28 kg/m2
Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
Smoking or nicotine use
Ongoing medical therapy (other than birth control)
Ongoing use of over-the-counter or prescription antihistamines
Allergies or hypersensitivities to drugs, local anesthetics, skin disinfectants, adhesives, or latex
Pregnant, breastfeeding subjects, or planning to become pregnant in the next 12 months
Mobility restrictions that interfere with physical activity
High physical activity based on International Physical Activity Questionaire (IPAQ1)
Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oregon	Eugene	Oregon	United States	97403

Sponsors and Collaborators

University of Oregon

Investigators

Principal Investigator: John R Halliwill, PhD, University of Oregon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oregon

ClinicalTrials.gov Identifier:

NCT05206227

Other Study ID Numbers:

Uoregon_STUDY0000001

First Posted:

Jan 25, 2022

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Oregon

Histamine

Mast cell

Exercise

Additional relevant MeSH terms:

Post-Exercise Hypotension

Hypotension

Study Results

No Results Posted as of Feb 8, 2022