CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Hypobaric +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06408558
NCT06408558N/ACompleted

he Effect of Altitude and Simulated Flight in a Hypobaric Chamber on Glucose Metabolism and the in Vivo Performance of Insulin Delivery Systems

University of Surrey·interventional·Posted May 10, 2024·Updated Dec 17, 2024

In Brief

A clinical study evaluating Hypobaric and Ground level for Type1 Diabetes. Completed, enrolled 6 participants across 1 site.

Detailed Summary

Atmospheric pressure can influence how the body handles blood glucose. At high elevations, atmospheric pressure decreases. Research shows that both the elevation and the length of stay at that elevation can influence the body's glucose response. The investigators would like to find out if the change in pressure in the cabin environment during a flight affects the body's handling of glucose. Commercial planes usually fly at 40000 feet (12192 m) but the cabin pressure is re-pressurized to 8000 feet (2438 m) with cabin pressure fixed at 560 mmHg. The normal atmospheric pressure at sea level is 760 mmHg. Since the investigators cannot perform the studies in an aeroplane, a hypobaric chamber will be used to set to this low pressure which will reproduce the cabin environment during a commercial flight. The chamber is located at the research and development company, QinetiQ, MOD Boscombe. The objective of this study is to compare the effect of atmospheric pressure on glucose metabolism during simulated flight conditions during fasting and in response to a mixed liquid meal. This will involve attending three visits; visit 1 (screening), visit 2 and visit 4 and two phone visits. The duration of the study is 15 days or 1 month depending on the participant's availability. Visit 1, informed consent and screening, will take place at CEDAR, Royal Surrey County Hospital, Guildford, followed by two visits of the meal test in random order at CEDAR or QintetiQ, Visit 2, will be a meal test performed at 760 mmHg OR at 560mmHg. Visit 4, will be a further meal test at 560 mmHg OR 760 mmHg. The order of the meal test visits at different ambient pressures will be randomised. The two phone visits will take place the day after the meal test days to enquire about the patient's health after the test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1 Diabetes
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 10, 2024
Enrollment StartJan 28, 2023
Primary CompletionJan 7, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.1 years ago

Interventions

Hypobaricother

The effects of ambient pressure changes on glucose metabolism will be studied

Ground levelother

The effects of ambient pressure changes on glucose metabolism will be studied