Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers (FlyBar)
Type 2 Diabetes
About this trial
This is an interventional prevention trial for Type 2 Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Placebo
soy isoflavones
soy isoflavones & cocoa polyphenols
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%)