Histamine as a Molecular Transducer of Adaptation to Exercise
Primary Purpose
Postexercise Hypotension
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
alpha-FMH
Resistance and Aerobic Exercise
Antihistamine
Sponsored by
About this trial
This is an interventional basic science trial for Postexercise Hypotension focused on measuring Histamine, Mast cell, Exercise
Eligibility Criteria
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
Sites / Locations
- University of OregonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Aerobic Exercise
Heating
Resistance and Aerobic Exercise
Aerobic Exercise and Muscle Perfusion
Arm Description
Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise
Blood and skeletal muscle microdialysate collected during local and/or whole body heating
Blood and urine collected during recovery from two modalities of exercise
Muscle perfusion measured during aerobic exercise
Outcomes
Primary Outcome Measures
Percentage of mast cell degranulation
Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals
Histamine concentration
Histamine concentration in intramuscular dialysate
Histamine metabolites
Concentration of histamine metabolites in blood and urine
Muscle perfusion
Skeletal muscle tissue oxygen index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05206227
Brief Title
Histamine as a Molecular Transducer of Adaptation to Exercise
Official Title
Histamine as a Molecular Transducer of Adaptation to Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postexercise Hypotension
Keywords
Histamine, Mast cell, Exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise
Arm Title
Heating
Arm Type
Experimental
Arm Description
Blood and skeletal muscle microdialysate collected during local and/or whole body heating
Arm Title
Resistance and Aerobic Exercise
Arm Type
Experimental
Arm Description
Blood and urine collected during recovery from two modalities of exercise
Arm Title
Aerobic Exercise and Muscle Perfusion
Arm Type
Experimental
Arm Description
Muscle perfusion measured during aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Subjects will complete a single bout of aerobic exercise.
Intervention Type
Drug
Intervention Name(s)
alpha-FMH
Other Intervention Name(s)
Heating
Intervention Description
Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.
Intervention Type
Behavioral
Intervention Name(s)
Resistance and Aerobic Exercise
Intervention Description
Subjects will complete bouts of resistance and aerobic exercise.
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Intervention Description
Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.
Primary Outcome Measure Information:
Title
Percentage of mast cell degranulation
Description
Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals
Time Frame
One hour
Title
Histamine concentration
Description
Histamine concentration in intramuscular dialysate
Time Frame
One hour
Title
Histamine metabolites
Description
Concentration of histamine metabolites in blood and urine
Time Frame
24 hours
Title
Muscle perfusion
Description
Skeletal muscle tissue oxygen index
Time Frame
One hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John R Halliwill, PhD
Phone
541-600-4337
Email
halliwil@uoregon.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher T Minson, PhD
Phone
541-953-2231
Email
minson@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Halliwill, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John R Halliwill, PhD
Phone
541-632-4151
Email
halliwil@uoregon.edu
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD
Phone
541-953-2231
Email
minson@uoregon.edu
First Name & Middle Initial & Last Name & Degree
John R Halliwill, PhD
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Histamine as a Molecular Transducer of Adaptation to Exercise
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