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Histamine as a Molecular Transducer of Adaptation to Exercise

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University of Oregon

Status and phase

Enrolling
Early Phase 1

Conditions

Postexercise Hypotension

Treatments

Behavioral: Resistance and Aerobic Exercise
Drug: alpha-FMH
Behavioral: Aerobic Exercise
Drug: Antihistamine

Study type

Interventional

Funder types

Other

Identifiers

NCT05206227
STUDY00001088 (Other Identifier)
Uoregon_STUDY0000001
STUDY00000982 (Other Identifier)
STUDY00000718

Details and patient eligibility

About

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

Full 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. 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 4 patient groups

Aerobic Exercise
Experimental group
Description:
Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise
Treatment:
Behavioral: Aerobic Exercise
Heating
Experimental group
Description:
Blood and skeletal muscle microdialysate collected during local and/or whole body heating
Treatment:
Drug: alpha-FMH
Resistance and Aerobic Exercise
Experimental group
Description:
Blood and urine collected during recovery from two modalities of exercise
Treatment:
Behavioral: Resistance and Aerobic Exercise
Aerobic Exercise and Muscle Perfusion
Experimental group
Description:
Muscle perfusion measured during aerobic exercise
Treatment:
Drug: Antihistamine
Behavioral: Aerobic Exercise

Trial contacts and locations

1

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Central trial contact

Christopher T Minson, PhD; John R Halliwill, PhD

Data sourced from clinicaltrials.gov

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