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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Other | 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%) |
|
| soy isoflavones | Other | 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%) |
|
| soy isoflavones & cocoa polyphenols | Other | 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%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxia | Other |
| ||
| Low Humidity |
| 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 |
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Inclusion Criteria:
Diabetes group:
Healthy volunteers group:
Exclusion Criteria:
For both groups:
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| Name | Affiliation | Role |
|---|---|---|
| Sathyapalan Thozhukat, MBBS MD | University of Hull, UK | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29487564 | Result | 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. |
| Label | URL |
|---|---|
| Publication Link | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C505729 | SLH1 protein, Arabidopsis |
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| Other |
|
| D004700 | Endocrine System Diseases |