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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia

Other

Low Humidity

Other

Primary outcomes

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

Time frame: Change from Baseline to 2 hours

To determine the effect of hypoxia and low humidity on the endothelial function in healthy volunteers and patients with type 2 diabetes

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: FlyBar

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jul 24, 2019
Registry last updated: Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed