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

NCT04031417 | Completed

• 1 other identifier: R1276
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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%)

Other: Hypoxia; Other: Low Humidity

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%)

Other: Hypoxia; Other: Low Humidity

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%)

Other: Hypoxia; Other: Low Humidity

Interventions

Hypoxia OTHER

Placebo; soy isoflavones; soy isoflavones & cocoa polyphenols

Low Humidity OTHER

Placebo; soy isoflavones; soy isoflavones & cocoa polyphenols

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Related 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 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.

  PMID: 29487564 RESULT

Related Links

• Publication Link

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SLH1 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sathyapalan Thozhukat, MBBS MD

  University of Hull, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 24, 2019
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 18, 2022

Record last verified: 2022-08