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

Type 2 Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031417
• Other study ID #: R1276
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2022
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Hypoxia

• Low Humidity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust

References & Publications (1)

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 P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Publication Link