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

Study Overview
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Brief Summary
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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.

Official Title
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Modelling Endothelial Function With Hypoxia and Low Humidity (Simulated Flight Environment) in Healthy Volunteers and Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Hypoxia
* Other: Low Humidity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo<br>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%) | Other: Hypoxia<br> <br> Other: Low Humidity<br> <br> |
| Other: soy isoflavones<br>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%) | Other: Hypoxia<br> <br> Other: Low Humidity<br> <br> |
| Other: soy isoflavones & cocoa polyphenols<br>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%) | Other: Hypoxia<br> <br> Other: Low Humidity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from Baseline to 2 hours |