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Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers (FlyBar)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoxia
Low Humidity
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Diabetes group:

  • Diagnosis of type 2 diabetes
  • Patients on stable medication (for their diabetes metformin being the only treatment if any), for 3 months prior to entry into the study
  • Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing hormone replacement therapy (HRT)

Healthy volunteers group:

  • No current disease or medication which would have effect on the safety of the subjects or interfere with the study results
  • Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing HRT

Exclusion Criteria:

  • For both groups:

    • Patients with concurrent illness or any medication in the last 3 months that would interfere with the study based on the investigator's judgement
    • Acute coronary syndrome in the last 3 months or any major clinical event in the previous 3 months that would effect the study based on the investigator's judgement
    • Patients not wishing to allow disclosure to their general practitioner (GP)s.
    • HbA1c >9%
    • Smokers
    • Pre-menopausal women or post-menopausal women on HRT
    • Claustrophobia, panic attacks in the anamnesis
    • Subjects must not have been subjected to a commercial flight within 4 weeks of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Placebo

    soy isoflavones

    soy isoflavones & cocoa polyphenols

    Arm Description

    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)

    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)

    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)

    Outcomes

    Primary Outcome Measures

    Hypoxia and low humidity on the endothelial function in healthy volunteers and patients with type 2 diabetes using Wilcoxon signed rank test
    To determine the effect of hypoxia and low humidity on the endothelial function in healthy volunteers and patients with type 2 diabetes

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2019
    Last Updated
    August 16, 2022
    Sponsor
    Hull University Teaching Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04031417
    Brief Title
    Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers
    Acronym
    FlyBar
    Official Title
    Modelling Endothelial Function With Hypoxia and Low Humidity (Simulated Flight Environment) in Healthy Volunteers and Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hull University Teaching Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Diabetes is an increasingly common condition which affects millions of people in the United Kingdom. Patients with type 2 diabetes are at increased risk to develop severe heart disease and vascular complications and these can result in death. A cornerstone of the treatment is lifestyle and diet. The number of travellers is increasing quickly and there are more people than ever travelling by airplane. During a commercial flight the pressure of the air is lower than the pressure on the surface and that results in lower concentration of oxygen in the air we are breathing while flying. Also the humidity is very low inside an aircraft. The aims of this study are to show if we can use a simulated flight as a method to look at how the endothelial cells react and to see if this is different between patients with type 2 diabetes mellitus and healthy volunteers. A sub-study is also incorporated to look at different dietary interventions in type 2 diabetes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Other
    Arm Description
    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)
    Arm Title
    soy isoflavones
    Arm Type
    Other
    Arm Description
    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)
    Arm Title
    soy isoflavones & cocoa polyphenols
    Arm Type
    Other
    Arm Description
    Spend 2 hours in an environmental chamber at sea level conditions (temperature : 23c, oxygen concentration 21 %, humidity 45%) Spend 2 hours in a simulated flight (temperature 23c, oxygen concentration 15%, humidity 15%)
    Intervention Type
    Other
    Intervention Name(s)
    Hypoxia
    Intervention Type
    Other
    Intervention Name(s)
    Low Humidity
    Primary Outcome Measure Information:
    Title
    Hypoxia and low humidity on the endothelial function in healthy volunteers and patients with type 2 diabetes using Wilcoxon signed rank test
    Description
    To determine the effect of hypoxia and low humidity on the endothelial function in healthy volunteers and patients with type 2 diabetes
    Time Frame
    Change from Baseline to 2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diabetes group: Diagnosis of type 2 diabetes Patients on stable medication (for their diabetes metformin being the only treatment if any), for 3 months prior to entry into the study Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing hormone replacement therapy (HRT) Healthy volunteers group: No current disease or medication which would have effect on the safety of the subjects or interfere with the study results Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing HRT Exclusion Criteria: For both groups: Patients with concurrent illness or any medication in the last 3 months that would interfere with the study based on the investigator's judgement Acute coronary syndrome in the last 3 months or any major clinical event in the previous 3 months that would effect the study based on the investigator's judgement Patients not wishing to allow disclosure to their general practitioner (GP)s. HbA1c >9% Smokers Pre-menopausal women or post-menopausal women on HRT Claustrophobia, panic attacks in the anamnesis Subjects must not have been subjected to a commercial flight within 4 weeks of the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sathyapalan Thozhukat, MBBS MD
    Organizational Affiliation
    University of Hull, UK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29487564
    Citation
    Konya J, Spurgeon BEJ, Al Qaissi A, Sathyapalan T, Ajjan R, Madden L, Naseem KM, Garrett AT, Kilpatrick E, Atkin SL. The Effect of a Simulated Commercial Flight Environment with Hypoxia and Low Humidity on Clotting, Platelet, and Endothelial Function in Participants with Type 2 Diabetes - A Cross-over Study. Front Endocrinol (Lausanne). 2018 Feb 13;9:26. doi: 10.3389/fendo.2018.00026. eCollection 2018. Erratum In: Front Endocrinol (Lausanne). 2018 Jun 07;9:301.
    Results Reference
    result
    Links:
    URL
    https://www.frontiersin.org/articles/10.3389/fendo.2018.00026/full
    Description
    Publication Link

    Learn more about this trial

    Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers

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