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Effects of Respiratory Muscle Exercises on Glucose Tolerance in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04520763
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Study Description
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Brief Summary:
To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test.

Condition or disease Intervention/treatment Phase
Healthy Aging Healthy Diet Other: 5min respiratory muscle exercises Other: 15min respiratory muscle exercises Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study consists of four visits to the laboratory, each separated by at least 24 hours and each lasting approximately 2.5h. Total duration for each participant is approximately 2 weeks. The study is conducted in 40 healthy adults (≥ 18 years). The study is a randomized, controlled cross-over trial. We chose a cross-over design in order to test the effects of different respiratory exercises compared to a control intervention in order to minimize variability since each subject serves as his/her own control. Due to the nature of the intervention (respiratory muscle exercises), it is not possible to blind participants to the interventions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Respiratory Muscle Exercises on Glucose Tolerance in Healthy Adults
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Respiratory Muscle Exercises
Two respiratory muscle exercises
 Other: 5min respiratory muscle exercises
5 min of hyperpnea at a target intensity of 60-80% MVV 15-30min after ingestion of 75g of glucose

Other: 15min respiratory muscle exercises
5 min of hyperpnea at a target intensity of 60-70% MVV 15-30min after ingestion of 75g of glucose
No Intervention: Control
The control intervention consists of quiet sitting for 15 min


Outcome Measures
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Primary Outcome Measures :
  1. Peak blood glucose concentration [ Time Frame: throughout the study, an expected average of 2 weeks per participant ]
    Peak blood glucose concentration will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).

  2. area under the glucose-time curve [ Time Frame: throughout the study, an expected average of 2 weeks per participant ]
    Area under the glucose-time curve will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Healthy
  • Non-smoking
  • Body mass index (BMI): 18.5 - 29.9 kg∙m-2
  • Normal lung function
  • Willing to adhere to study rules

Exclusion Criteria:

  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Intake of medications affecting metabolism, the cardiovascular or the respiratory system, or sleep
  • Acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
  • Pregnancy, breastfeeding, or intention to become pregnant during the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520763


Contacts
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Contact: Christina M. Spengler, Prof. +41 44 635 5007 christina.spengler@hest.ethz.ch

Locations
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Switzerland
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich Recruiting
Zürich, ZH, Switzerland, 8057
Contact: Christina M. Spengler, Prof.    +41 44 635 5007    christina.spengler@hest.ethz.ch   
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
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Principal Investigator: Christin M. Spengler, Prof. Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
More Information
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04520763    
Other Study ID Numbers: HOGTT_2020
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No