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Histamine Modulation for Low Blood Pressure
Phase < 1
Recruiting
Led By John R Halliwill, PhD
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 -40
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour
Awards & highlights
Study Summary
This trial is testing if a substance released from muscles during exercise can cause mast cells to release their contents.
Who is the study for?
This trial is for healthy adults aged 18-40 who have not been diagnosed with cardiovascular disease, diabetes, autonomic disorders, or asthma. Participants should not smoke or use nicotine and must not be on any antihistamines or ongoing medical therapy (except birth control). They cannot be pregnant, breastfeeding, planning pregnancy soon, highly active physically, overweight (BMI over 28), non-English speaking, or have high blood pressure.Check my eligibility
What is being tested?
The study examines how histamine helps the body adapt to exercise by comparing the effects of aerobic exercise alone versus combined resistance and aerobic exercise. It also tests the impact of blocking histamine with a drug called alpha-FMH and using common antihistamines after exercising.See study design
What are the potential side effects?
Potential side effects may include reactions to alpha-FMH such as headaches or nausea; typical antihistamine side effects like drowsiness or dry mouth; and general exercise-related discomforts including muscle soreness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Histamine concentration
Histamine metabolites
Muscle perfusion
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Resistance and Aerobic ExerciseExperimental Treatment1 Intervention
Blood and urine collected during recovery from two modalities of exercise
Group II: HeatingExperimental Treatment1 Intervention
Blood and skeletal muscle microdialysate collected during local and/or whole body heating
Group III: Aerobic Exercise and Muscle PerfusionExperimental Treatment2 Interventions
Muscle perfusion measured during aerobic exercise
Group IV: Aerobic ExerciseExperimental Treatment1 Intervention
Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1310
Antihistamine
2016
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
University of OregonLead Sponsor
80 Previous Clinical Trials
46,826 Total Patients Enrolled
John R Halliwill, PhDPrincipal InvestigatorUniversity of Oregon
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high level of physical activity based on the International Physical Activity Questionnaire.I am currently on medication other than birth control.You are allergic to certain drugs, anesthetics, skin disinfectants, adhesives, or latex.I am between 18 and 40 years old.You are a smoker or use nicotine products.I have been diagnosed with heart disease, diabetes, an autonomic disorder, or asthma.I regularly use antihistamines.I have difficulty moving around which affects my physical activity.Your blood pressure is higher than 120 when the heart beats.Your diastolic blood pressure is 80 or higher.You weigh more than what is considered healthy for your height.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic Exercise
- Group 2: Heating
- Group 3: Resistance and Aerobic Exercise
- Group 4: Aerobic Exercise and Muscle Perfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the criteria to take part in this research endeavor?
"This research initiative is seeking to enroll 20 individuals that experience postexercise hypotension and are aged between 18 and 40. Prospective applicants must fulfill the age requirement for consideration."
Answered by AI
Are there vacancies available for participants in this experiment?
"According to clinicaltrials.gov, this study is actively soliciting volunteers and has been since July 28th 2021 with the most recent iteration of the trial being published on January 24th 2022."
Answered by AI
Does this trial accept participants younger than 75 years old?
"To be considered eligible for this experiment, prospective participants must fall in the 18 to 40 year old age range. There are 7 trials dedicated specifically to minors and 90 that focus on people 65 years or older."
Answered by AI
What is the scope of participant recruitment for this experiment?
"Affirmative, clinicaltrials.gov confirms that this study is actively recruiting individuals to participate. It was first posted on July 28th 2021 and the information has been updated as recently as January 24th 2022. The goal of the trial is to enlist 20 people between one medical centre."
Answered by AI
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