Histamine as a Molecular Transducer of Adaptation to Exercise

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

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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