Trial Outcomes & Findings for The Effect of Hypoxia on Type 2 Diabetes and Weight Loss (NCT NCT05147116)
NCT ID: NCT05147116
Last Updated: 2025-01-24
Results Overview
Does 10 days of overnight hypoxia change AUC during a oral glucose tolerance test. Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+...+(yn/2)). Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
COMPLETED
NA
22 participants
Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.
2025-01-24
Participant Flow
Participant milestones
| Measure |
Hypoxia 15% O2 - Sham (Room Air) 21% O2
Participants will sleep in a tent for 10 nights in hypoxia. They will then have a 3 month washout, crossover and do another 10 nights but in normoxia.
|
Sham (Room Air) 21% 02 - Hypoxia 15% O2
Participants will sleep in a tent for 10 nights in normoxia. They will then have a 3 month washout, crossover and do another 10 nights but in hypoxia.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Hypoxia 15% O2 - Sham (Room Air) 21% O2
Participants will sleep in a tent for 10 nights in hypoxia. They will then have a 3 month washout, crossover and do another 10 nights but in normoxia.
|
Sham (Room Air) 21% 02 - Hypoxia 15% O2
Participants will sleep in a tent for 10 nights in normoxia. They will then have a 3 month washout, crossover and do another 10 nights but in hypoxia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=13 Participants
As this is a within-subject, repeated measures RCT, participant characteristics are presented as one.
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9 • n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=13 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=13 Participants
|
|
Height
|
1.72 m
STANDARD_DEVIATION 0.09 • n=13 Participants
|
|
Mass
|
87.5 kg
STANDARD_DEVIATION 14.6 • n=13 Participants
|
|
BMI
|
29.7 kg/m2
STANDARD_DEVIATION 3.9 • n=13 Participants
|
|
HbA1c
|
61.1 mmol/mol
STANDARD_DEVIATION 14.1 • n=13 Participants
|
|
T2DM duration
|
9.3 years
STANDARD_DEVIATION 7 • n=13 Participants
|
|
SBP
|
132 mmHg
STANDARD_DEVIATION 13 • n=13 Participants
|
|
DBP
|
80 mmHg
STANDARD_DEVIATION 11 • n=13 Participants
|
PRIMARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Does 10 days of overnight hypoxia change AUC during a oral glucose tolerance test. Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+...+(yn/2)). Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=11 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=11 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ Mean AUC (Area Under the Curve) Plasma [Glucose]
|
-17.7 mmol.min.L-1
Standard Deviation 237.7
|
54.9 mmol.min.L-1
Standard Deviation 226.1
|
SECONDARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Population: Within-subject cross-over trial. Total still did not exceed 13.
Does 10 days of overnight hypoxia change body mass - assessed via DXA. Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=13 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=12 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ Body Mass
|
0 kg
Standard Deviation 0.9
|
-0.7 kg
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Population: Within-subject crossover trial. Therefore total is still 10.
Does 10 days of overnight hypoxia change physical activity - assessed via wrist worn accelerometry. Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=10 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=10 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ Total Minutes of Physical Activity (Light, Moderate, Moderate to Vigorous Physical Activity).
|
170 min
Interval 103.0 to 237.0
|
183 min
Interval 116.0 to 250.0
|
SECONDARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Population: Within-subject crossover trial. Therefore total is still 10.
Does 10 days of overnight hypoxia change sleep - assessed via wrist worn accelerometry. Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=10 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=10 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ Sleep Efficiency (Percentage of Time Spent Asleep While in Bed)
|
88 % of time spent asleep while
Interval 79.0 to 97.0
|
86 % of time spent asleep while
Interval 78.0 to 94.0
|
SECONDARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Population: Within-subject crossover trial. Therefore total is still 12.
Does 10 days of overnight hypoxia change IL-6. Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=12 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=12 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ IL-6
|
1.06 pg/mL
Interval -1.66 to 3.78
|
-0.55 pg/mL
Interval -2.08 to 0.98
|
SECONDARY outcome
Timeframe: Assessed on all outcome visits (2,3,4&5) across an 8 week period. Δ from pre-post hypoxia visits are calculated and compared to Δ from pre-post sham visits.Population: Within-subject crossover trial. Therefore total is still 12.
Does 10 days of overnight hypoxia change TNFɑ. Due to the study design being a randomised crossover control trial, the results for visits 2 and 3, and, 4 and 5, have been unrandomized into the delta of pre-post hypoxia and sham interventions. Visits 2 and 4 represent baseline compared to visit 3 and 5 respectively.
Outcome measures
| Measure |
Hypoxia 15% O2
n=12 Participants
Participants will sleep in a tent for 10 nights in hypoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
Sham (Room Air) 21% O2
n=12 Participants
Participants will sleep in a tent for 10 nights in normoxia.
Sleeping in a tent: Participants will spend 10 consecutive nights of sleeping in a tent
|
|---|---|---|
|
Δ TNFɑ
|
0.66 pg/mL
Interval -2.06 to 3.38
|
0.61 pg/mL
Interval -1.75 to 2.97
|
Adverse Events
Hypoxia 15% O2
Sham (Room Air) 21% O2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place