Histamine as a Molecular Transducer of Adaptation to Exercise

Postexercise Hypotension Clinical Trial

Official title:

Histamine as a Molecular Transducer of Adaptation to Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206227
• Other study ID #: Uoregon_STUDY0000001
• Secondary ID: STUDY00000718STU
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 28, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: August 2023
• Source: University of Oregon
• Contact: John R Halliwill, PhD
• Phone: 541-600-4337
• Email: halliwil[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Post-Exercise Hypotension
• Postexercise Hypotension

Intervention

Behavioral:
• Aerobic Exercise
Subjects will complete a single bout of aerobic exercise.

Drug:
• alpha-FMH
Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.

Behavioral:
• Resistance and Aerobic Exercise
Subjects will complete bouts of resistance and aerobic exercise.

Drug:
• Antihistamine
Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

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