Histamine H1/H2 Receptors and Training Adaptations

• Sponsor: Wim Derave (Other)
• Overall Status: Completed
• CT.gov ID: NCT04450134
• Collaborator: Research Foundation Flanders (Other), University of Copenhagen (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Exercise training is beneficial for both health and performance. Histamine has been shown to be involved in the acute exercise response. The current study addresses the role of histamine H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.

Condition or Disease	Intervention/Treatment	Phase
Exercise Training; Physical Activity	Other: Lactose; Drug: Fexofenadine Hydrochloride; Drug: Famotidine; Other: High-intensity interval training (HIIT)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Placebo + exercise vs histamine blockade + exercisePlacebo + exercise vs histamine blockade + exercise
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind for researchers and participants
• Primary Purpose: Basic Science
• Official Title: Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training
• Actual Study Start Date: Oct 2, 2019
• Actual Primary Completion Date: Dec 18, 2019
• Actual Study Completion Date: Apr 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 6 weeks high-intensity interval training + placebo intake	Other: Lactose; Placebo: Lactose capsules; Other: High-intensity interval training (HIIT); 6 weeks HIIT
Experimental: Blockade 6 weeks high-intensity interval training + histamine H1/H2 receptor blockade	Drug: Fexofenadine Hydrochloride; H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride; Drug: Famotidine; H2 receptor antagonist: 40 mg Famotidine; Other: High-intensity interval training (HIIT); 6 weeks HIIT

Outcome Measures

Primary Outcome Measures

1. Change in cardiorespiratory fitness [Before, after 3 weeks and after 6 weeks of exercise training]

   Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period

2. Change in peak aerobic power output [Before, after 3 weeks and after 6 weeks of exercise training]

   Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period

3. Change in whole-body insulin sensitivity [Before and after 6 weeks of exercise training]

   Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period

4. Change in microvascular function [Before and after 6 weeks of exercise training]

   Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period

Secondary Outcome Measures

1. Change in skeletal muscle capillarization [Before and after 6 weeks of exercise training]

   Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period

2. Change in skeletal muscle enzyme activity [Before and after 6 weeks of exercise training]

   Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period

3. Change in skeletal muscle protein content [Before and after 6 weeks of exercise training]

   Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period

4. Change in power output at Gas Exchange Threshold (GET) [Before, after 3 weeks and after 6 weeks of exercise training]

   Change from baseline in GET during incremental cycling test after the 6 week training period

5. Change in power output at Respiratory Compensation Point (RCP) [Before, after 3 weeks and after 6 weeks of exercise training]

   Change from baseline in RCP during incremental cycling test after the 6 week training period

6. Change in time to exhaustion performance test [Before, after 3 weeks and after 6 weeks of exercise training]

   Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period

7. Change in heart rate during submaximal cycling [Before and after 6 weeks of exercise training]

   Change from baseline in heart rate during submaximal cycling after the 6 week training period

8. Change in substrate oxidation during submaximal cycling [Before and after 6 weeks of exercise training]

   Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period

9. Change in blood lactate accumulation during submaximal cycling [Before and after 6 weeks of exercise training]

   Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period

10. Change in cycling efficiency during submaximal cycling [Before and after 6 weeks of exercise training]

    Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period

11. Change in fasted serum insulin concentrations [Before and after 6 weeks of exercise training]

    Change from baseline in fasted blood concentrations of insulin after the 6 week training period

12. Change in fasted serum glucose concentrations [Before and after 6 weeks of exercise training]

    Change from baseline in fasted blood concentrations of glucose after the 6 week training period

13. Change in fasted serum cholesterol concentrations [Before and after 6 weeks of exercise training]

    Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period

14. Change in fasted serum triglyceride concentrations [Before and after 6 weeks of exercise training]

    Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period

15. Change in resting blood pressure [Before and after 6 weeks of exercise training]

    Change from baseline in resting mean arterial blood pressure after the 6 week training period

16. Change in resting heart rate [Before and after 6 weeks of exercise training]

    Change from baseline in resting heart rate after the 6 week training period

17. Change in body weight [Before and after 6 weeks of exercise training]

    Change from baseline in total body weight after the 6 week training period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Sedentary or low levels of physical activity

• Caucasian

Exclusion Criteria:

• Chronic diseases

• Medication use

• Smoking

• Excessive alcohol consumption

• Seasonal allergies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Movement and Sports Sciences, Ghent University	Gent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

• Wim Derave
• Research Foundation Flanders
• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wim Derave, Professor, University Ghent
• ClinicalTrials.gov Identifier: NCT04450134
• Other Study ID Numbers: HIST-TRAINING
• First Posted: Jun 29, 2020
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wim Derave, Professor, University Ghent: Exercise; Physiology
• Additional relevant MeSH terms: Fexofenadine; Famotidine

Study Results

No Results Posted as of Jul 30, 2021