Histamine as a Molecular Transducer of Adaptation to Exercise

Early Phase 1

Recruiting

• Conditions: Postexercise Hypotension
• Interventions: Behavioral: Aerobic Exercise; Drug: alpha-FMH; Behavioral: Resistance and Aerobic Exercise; Drug: Antihistamine

• Registration Number: NCT05206227
• Lead Sponsor: University of Oregon

Brief Summary

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

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. 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.

Study Timeline

• Study Start: 2021-07-28
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Muscle perfusion	One hour	Skeletal muscle tissue oxygen index
Histamine concentration	One hour	Histamine concentration in intramuscular dialysate
Histamine metabolites	24 hours	Concentration of histamine metabolites in blood and urine
Percentage of mast cell degranulation	One hour	Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals

Trial Locations

Locations (1)

University of Oregon; 🇺🇸 Eugene, Oregon, United States