Histamine as a Molecular Transducer of Adaptation to Exercise

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

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2027-03-31

Brief Summary

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This study is investigating the role of histamine in generating adaptation to exercise

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Detailed Description

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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. Participants will perform exercise or participate in interventions like heating that may replicate some of the effects of exercise. During most experiments, 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 or undergo heating.

Conditions

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Postexercise Hypotension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a series of Basic Experimental Studies with Humans (BESH, as defined by PA-20-184). Subjects are enrolled (non-randomized) in different arms of the overall study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aerobic Exercise

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

Subjects will complete a single bout of aerobic exercise.

Heating

Blood and skeletal muscle microdialysate collected during local and/or whole body heating

Group Type EXPERIMENTAL

alpha-FMH

Intervention Type DRUG

Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.

Resistance and Aerobic Exercise

Blood and urine collected during recovery from two modalities of exercise (This arm is now CLOSED)

Group Type EXPERIMENTAL

Resistance and Aerobic Exercise

Intervention Type BEHAVIORAL

Subjects will complete bouts of resistance and aerobic exercise.

Aerobic Exercise and Muscle Perfusion

Muscle perfusion measured during aerobic exercise (This arm is now CLOSED)

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

Subjects will complete a single bout of aerobic exercise.

Antihistamine

Intervention Type DRUG

Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.

Interventions

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Aerobic Exercise

Subjects will complete a single bout of aerobic exercise.

Intervention Type BEHAVIORAL

alpha-FMH

Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.

Intervention Type DRUG

Resistance and Aerobic Exercise

Subjects will complete bouts of resistance and aerobic exercise.

Intervention Type BEHAVIORAL

Antihistamine

Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.

Intervention Type DRUG

Other Intervention Names

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Heating

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes