Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408558
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-04-24
Brief Title:
Safe Use of New Technologies in Diabetes in Flight
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
he Effect of Altitude and Simulated Flight in a Hypobaric Chamber on Glucose Metabolism and the in Vivo Performance of Insulin Delivery Systems
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUNDIF
Brief 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 bodys glucose response
The investigators would like to find out if the change in pressure in the cabin environment during a flight affects the bodys 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 participants 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 patients health after the test
The investigators would like to find out if the change in pressure in the cabin environment during a flight affects the bodys 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 participants 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 patients health after the test
Detailed Description:
The study is a randomised crossover study at two different ambient pressures one at normal ambient pressure 760 mmHg and the other at 560 mmHg mimicking the repressurised cabin environment at 8000 feet Participants will have three visits and two phone visits Visit 1 is the screening visit Visit 2 will be a meal test MT performed at 760 mmHg OR at 560mmHg Visit 4 will be a further MT at 560 mmHg OR 760 mmHg The order of MT test visits at different ambient pressures will be randomised The two phone visits will take place the day after the MT assessment days visit 3 and 5 with prior arrangement to enquire about the patients health after the test The expected duration of participant participation is approximately 15 days
Screening visit 1 can also be performed before the first test meal on the visit 2 before any visit 2 activities can take place
Randomisation procedure The participant will be assigned a study identification number and randomised for the study procedures in random order at different ambient pressures at 760 mmHg and 560 mmHg Randomisation for the order of the two meal studies ie at 760 mmHg and at 560mmHg will take place at recruitment phase to accommodate the availability of the volunteers and the dates available at QinetiQ facility for the meal studies
The recruitment phase will commence as soon as there is ethical HRA research governance and regulatory approval and only after the Sponsor green light has been issued
Recruitment
Diabetes Clinics at Cedar centre Royal Surrey County Hospital
And UK CAA Clinic Aviation House Gatwick airport
Identification
Diabetes Consultants from diabetes clinics at the CEDAR Centre Royal Surrey County Hospital will identify participants with type 1 diabetes who are on pump therapy
The PI will identify participants with type 1 diabetes who are on pump therapy at UK CAA clinic Gatwick airport at the patients usual clinic visit
Screeningrun-in period Pilots with type 1 diabetes who are on pump therapy will be approached recruited at their usual UK-CAA clinic Aviation House Gatwick airport by Prof Russell-Jones Potential participants will be provided with a patient information sheet to take away and read
Patients with type 1 diabetes who are on pump therapy will be approached and recruited from CEDAR Centre RSCH Potential participants will be provided with a patient information sheet to take away and read
Visit 1 Screening and randomisation duration 1 h preformed at visit 1 or upon arrival on the morning of visit The screening and randomisation will take place at CEDAR RSCH CEDAR setting Patients recruited from CEDAR and UK CAA will be invited to a screening visit at CEDAR RSCH
Before screening takes place participants will be provided with verbal and written information about the trial and the procedures involved The participants will be fully informed of their responsibilities and rights while participating in this trial
Participants who wish to participate in the trial will be required to sign and date an Informed Consent Form prior to any trial-related activities taking place The PI on the site will seek informed consent from the participants All participants will be provided with a copy of the Participant Information Sheet and of their own signed and dated Informed Consent Form
Demographics age and sex
Medical History
Details of any medical condition or previous condition requiring surgical treatment will be recorded Including specific questions related to exclusion criteria
Concomitant Medication
Electrocardiogram ECG trace
Physical Examination- Vital Signs Weight kg height cm and total body fat mass will be recorded at screening visit and weight only at visit 2 and visit 4 Fat mass using Tanita body composition analyser will only be recorded once at the visit V2 or V4 taking place at CEDAR using bioimpedance scale Tanita
Body Mass Index BMI
Physical examination will include examination of
Safety required for hypobaric chamber conditions from QinetiQ will be examined
Laboratory Tests- plasma HbA1C Randomisation of participant once the eligibility for recruitment to the study is confirmed
The Metabolic Study- MEAL Test MT visit 2 4 performed in random order
Participants should refrain from alcohol for 24hours and strenuous exercise for 24 hours prior to any MT assessment day
The day before the MT As all participants will be using insulin pump therapy there will be no requirements for any insulin adjustments The participants will be asked not to consume food and drink only clear fluids from 2200 the day before the MT until the end of the MT The participants will attend the clinical research unit CEDAR RSCH at Surrey or QinetiQ MOD Boscombe Down Wiltshire at 700 am the morning of the MT
The morning of MT- Participants will arrive at QinetiQ or at Cedar centre at 7 am having fasted overnight Fasting blood glucose ideally should be between 4 and 8 mmolL During the study the participants capillary glucose concentration will be measured using a FreeStyle precision Pro Abbott glucose analyser The capillary glucose measurements will be recorded against the reading of the CGM glucose monitor The volume of insulin in the insulin pump will be checked and confirmed at 3ml
An ECG trace will be performed on the hypobaric visit day Visit 2 or Visit 4 Blood pressure will be measured at visit 2 and 4
An intravenous cannula will be inserted in an antecubital fossa of each arm one for blood sampling and the other for the infusion of the tracer 66 2H2 glucose The blood sampling cannula will be kept patent by flushing with saline after each blood sample Figure 2 Participants will be asked to empty bladder at -160 min before the study has begun
At -150 min baseline blood samples will be taken to measure blood glucose concentration and glucose enrichment by GCMS Baseline plasma metabolites and hormones will also be measured Plasma insulin aspart will be measured using an in-house kit at Celerion Denmark Glucagon concentration will be measured using radioimmunoassay Adrenaline and noradrenaline cortisol concentrations will be measured using enzyme linked immunoassays ELISA
Having taken the baseline sample a primed iv infusion of 6 6 2H2 glucose 6 mgkg 006mgkgmin will commence at -150 min Blood samples will be taken at 10 min intervals between -50 min and -30 min and 5 min intervals between -10 min and 0 min Ambient pressure will start changing at -30 min reaching decompression pressure at 560 mmHg at -10 min which will remain constant up to 180 min at which time the pressure will be increased gradually to normal pressure at 200min At 0 min a standardized liquid mixed meal Ensure Abbott Nutrition Ohio 78g carbohydrate consumed within 5 minutes containing U-13C glucose 170 g will be given to measure the meal-derived glucose appearance 11 The participants will be asked to give a standard-wave bolus of insulin where all bolus is delivered at once 01Ukg calculated by investigators 0-2 minutes before the standard meal test at 0 min The rate of 6 6 2H2 glucose infusion will be adjusted at predetermined intervals to mimic the expected endogenous glucose production Blood sampling will be continued following the meal intake at regular time points 10 20 30 60 75 90 120 150 180 and 210 min Infusion of 6 6 2H2 glucose will be stopped at 180 min
Vital signs and blood saturation will be measured every 1 h during the MT Ongoing the excreted urine volume and glucose concentration in urine will be measured Urine samples will be analysed for glucose excretion sugar in the urine and volume of urine excreted at 0 min before the meal drink and at the end of the study 180 minutes The urine will be collected at any other time during the study -150 min to 210 min if the patient required to use the toilet A sample of urine 1 ml will be centrifuged and stored at -80oC until analysis at a later date at the University of Surrey
While in the hypobaric chamber blood samples will be kept on ice until centrifugation Heraeus Labofuge 400 centrifuge Thermo Fisher Scientific UK every 60 min At CEDAR centre the MT will be carried out as in the hypobaric chamber but at normal ambient pressure 760 mmHg
All blood samples will be separated immediately after centrifugation every 60 min and the plasma stored at -20C at the CEDAR centre overnight and then transferred to a -80C freezer at the University of Surrey for analysis at a later date at the University of Surrey The samples from the QinetiQ study day will be stored on dry ice and then transferred to a -80C freezer at the University of Surrey for analysis at a later date at the University of Surrey
On completion of the metabolic assessment day participants will be reminded that they have the telephone number for the research team that can be used 24hours a day
Atmospheric pressure adjustments In the hypobaric chamber decompression will start at -30 min and will reach the required 560 mmHg mimicking cabin altitude of 8000 feet in 20 min The pressure in the chamber will start to increase gradually to 760 mmHg between 180 min and at 200 min a further sample will be taken at the end of study at 210 min
Screening visit 1 can also be performed before the first test meal on the visit 2 before any visit 2 activities can take place
Randomisation procedure The participant will be assigned a study identification number and randomised for the study procedures in random order at different ambient pressures at 760 mmHg and 560 mmHg Randomisation for the order of the two meal studies ie at 760 mmHg and at 560mmHg will take place at recruitment phase to accommodate the availability of the volunteers and the dates available at QinetiQ facility for the meal studies
The recruitment phase will commence as soon as there is ethical HRA research governance and regulatory approval and only after the Sponsor green light has been issued
Recruitment
Diabetes Clinics at Cedar centre Royal Surrey County Hospital
And UK CAA Clinic Aviation House Gatwick airport
Identification
Diabetes Consultants from diabetes clinics at the CEDAR Centre Royal Surrey County Hospital will identify participants with type 1 diabetes who are on pump therapy
The PI will identify participants with type 1 diabetes who are on pump therapy at UK CAA clinic Gatwick airport at the patients usual clinic visit
Screeningrun-in period Pilots with type 1 diabetes who are on pump therapy will be approached recruited at their usual UK-CAA clinic Aviation House Gatwick airport by Prof Russell-Jones Potential participants will be provided with a patient information sheet to take away and read
Patients with type 1 diabetes who are on pump therapy will be approached and recruited from CEDAR Centre RSCH Potential participants will be provided with a patient information sheet to take away and read
Visit 1 Screening and randomisation duration 1 h preformed at visit 1 or upon arrival on the morning of visit The screening and randomisation will take place at CEDAR RSCH CEDAR setting Patients recruited from CEDAR and UK CAA will be invited to a screening visit at CEDAR RSCH
Before screening takes place participants will be provided with verbal and written information about the trial and the procedures involved The participants will be fully informed of their responsibilities and rights while participating in this trial
Participants who wish to participate in the trial will be required to sign and date an Informed Consent Form prior to any trial-related activities taking place The PI on the site will seek informed consent from the participants All participants will be provided with a copy of the Participant Information Sheet and of their own signed and dated Informed Consent Form
Demographics age and sex
Medical History
Details of any medical condition or previous condition requiring surgical treatment will be recorded Including specific questions related to exclusion criteria
Concomitant Medication
Electrocardiogram ECG trace
Physical Examination- Vital Signs Weight kg height cm and total body fat mass will be recorded at screening visit and weight only at visit 2 and visit 4 Fat mass using Tanita body composition analyser will only be recorded once at the visit V2 or V4 taking place at CEDAR using bioimpedance scale Tanita
Body Mass Index BMI
Physical examination will include examination of
Safety required for hypobaric chamber conditions from QinetiQ will be examined
Laboratory Tests- plasma HbA1C Randomisation of participant once the eligibility for recruitment to the study is confirmed
The Metabolic Study- MEAL Test MT visit 2 4 performed in random order
Participants should refrain from alcohol for 24hours and strenuous exercise for 24 hours prior to any MT assessment day
The day before the MT As all participants will be using insulin pump therapy there will be no requirements for any insulin adjustments The participants will be asked not to consume food and drink only clear fluids from 2200 the day before the MT until the end of the MT The participants will attend the clinical research unit CEDAR RSCH at Surrey or QinetiQ MOD Boscombe Down Wiltshire at 700 am the morning of the MT
The morning of MT- Participants will arrive at QinetiQ or at Cedar centre at 7 am having fasted overnight Fasting blood glucose ideally should be between 4 and 8 mmolL During the study the participants capillary glucose concentration will be measured using a FreeStyle precision Pro Abbott glucose analyser The capillary glucose measurements will be recorded against the reading of the CGM glucose monitor The volume of insulin in the insulin pump will be checked and confirmed at 3ml
An ECG trace will be performed on the hypobaric visit day Visit 2 or Visit 4 Blood pressure will be measured at visit 2 and 4
An intravenous cannula will be inserted in an antecubital fossa of each arm one for blood sampling and the other for the infusion of the tracer 66 2H2 glucose The blood sampling cannula will be kept patent by flushing with saline after each blood sample Figure 2 Participants will be asked to empty bladder at -160 min before the study has begun
At -150 min baseline blood samples will be taken to measure blood glucose concentration and glucose enrichment by GCMS Baseline plasma metabolites and hormones will also be measured Plasma insulin aspart will be measured using an in-house kit at Celerion Denmark Glucagon concentration will be measured using radioimmunoassay Adrenaline and noradrenaline cortisol concentrations will be measured using enzyme linked immunoassays ELISA
Having taken the baseline sample a primed iv infusion of 6 6 2H2 glucose 6 mgkg 006mgkgmin will commence at -150 min Blood samples will be taken at 10 min intervals between -50 min and -30 min and 5 min intervals between -10 min and 0 min Ambient pressure will start changing at -30 min reaching decompression pressure at 560 mmHg at -10 min which will remain constant up to 180 min at which time the pressure will be increased gradually to normal pressure at 200min At 0 min a standardized liquid mixed meal Ensure Abbott Nutrition Ohio 78g carbohydrate consumed within 5 minutes containing U-13C glucose 170 g will be given to measure the meal-derived glucose appearance 11 The participants will be asked to give a standard-wave bolus of insulin where all bolus is delivered at once 01Ukg calculated by investigators 0-2 minutes before the standard meal test at 0 min The rate of 6 6 2H2 glucose infusion will be adjusted at predetermined intervals to mimic the expected endogenous glucose production Blood sampling will be continued following the meal intake at regular time points 10 20 30 60 75 90 120 150 180 and 210 min Infusion of 6 6 2H2 glucose will be stopped at 180 min
Vital signs and blood saturation will be measured every 1 h during the MT Ongoing the excreted urine volume and glucose concentration in urine will be measured Urine samples will be analysed for glucose excretion sugar in the urine and volume of urine excreted at 0 min before the meal drink and at the end of the study 180 minutes The urine will be collected at any other time during the study -150 min to 210 min if the patient required to use the toilet A sample of urine 1 ml will be centrifuged and stored at -80oC until analysis at a later date at the University of Surrey
While in the hypobaric chamber blood samples will be kept on ice until centrifugation Heraeus Labofuge 400 centrifuge Thermo Fisher Scientific UK every 60 min At CEDAR centre the MT will be carried out as in the hypobaric chamber but at normal ambient pressure 760 mmHg
All blood samples will be separated immediately after centrifugation every 60 min and the plasma stored at -20C at the CEDAR centre overnight and then transferred to a -80C freezer at the University of Surrey for analysis at a later date at the University of Surrey The samples from the QinetiQ study day will be stored on dry ice and then transferred to a -80C freezer at the University of Surrey for analysis at a later date at the University of Surrey
On completion of the metabolic assessment day participants will be reminded that they have the telephone number for the research team that can be used 24hours a day
Atmospheric pressure adjustments In the hypobaric chamber decompression will start at -30 min and will reach the required 560 mmHg mimicking cabin altitude of 8000 feet in 20 min The pressure in the chamber will start to increase gradually to 760 mmHg between 180 min and at 200 min a further sample will be taken at the end of study at 210 min
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None