An interventional study of Sleeping in a tent in Type2 Diabetes, sponsored by University of Portsmouth. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by University of Portsmouth · Not applicable, Interventional, and Other
The number of people with type 2 diabetes mellitus (T2DM) continuing to rise, this pandemic is expected to reach 700 million people by 2045. T2DM is a metabolic condition characterized by progressive insulin resistance and chronic hyperglycemia (high blood glucose concentrations). Hyperglycaemia increases the risk of both micro- and macrovascular damage, whilst interventions that reduce blood glucose mitigate this risk. Weight loss, achieved through exercise and dietary modification, is effective at reducing hyperglycaemia. However, despite the clear benefits of exercise and weight loss, diverse psychological, sociological and logistical factors can make it difficult for some individuals with T2DM to initiate, or adhere to, these lifestyle interventions. Alternative approaches to treatment are therefore required.
The purpose of this research project is to investigate whether 10-days of overnight exposure to moderate hypoxia is effective at improving blood glucose control in individuals with T2DM and to provide insight into the physiological mechanisms responsible for any beneficial effects.
Type 2 diabetes mellitus (T2DM) is a metabolic condition characterized by progressive insulin resistance and chronic hyperglycemia (high blood glucose concentrations). Hyperglycaemia increases the risk of both micro- and macrovascular damage, whilst interventions that reduce blood glucose mitigate this risk. Weight loss, achieved through exercise and dietary modification, is effective at reducing hyperglycaemia. However, despite the clear benefits of exercise and weight loss, diverse psychological, sociological and logistical factors can make it difficult for some individuals with T2DM to initiate, or adhere to, these lifestyle interventions. With the number of people with T2DM continuing to rise, this pandemic is expected to reach 700 million people by 2045. Thus, there is a clear need for cost-effective interventions that can effectively improve glycaemic control in people with T2DM and which people will adhere to.
A simple exposure to a lowered concentration of inspired oxygen (i.e. hypoxia) may represent such an intervention. In addition to the beneficial effects on glucose homeostasis that have been reported following a single acute hypoxic exposure, repeated intermittent, or continuous, hypoxic exposure may also have therapeutic potential in individuals with T2DM. In rodent models, daily hypoxic exposures returned fasting blood [glucose] to normal levels and increased glucose transporter 4 translocation in mice with T2DM. Similar effects on glucose homeostasis have been shown in overweight humans and those with insulin resistance, (during intermittent hypoxic training) which was explained, at least in part, by reduction in body mass (\~ 1.2 kg).
The mechanisms underpinning the improved glycaemic control in response to hypoxia are likely multifactorial. Specifically, our objective is to assess a novel therapeutic intervention for the treatment and management of T2DM which overcomes many of the barriers to uptake and adherence that are associated with some lifestyle interventions such as exercise and weight loss.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Portsmouth is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will sleep in a tent for 10 nights in hypoxia.
Other: Sleeping in a tent
Participants will sleep in a tent for 10 nights in normoxia.
Other: Sleeping in a tent
Participants will spend 10 consecutive nights of sleeping in a tent
Δ Mean AUC (Area Under the Curve) Plasma [Glucose]
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.
Time frame: 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.
Δ Body Mass
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.
Time frame: 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.
Δ Total Minutes of Physical Activity (Light, Moderate, Moderate to Vigorous Physical Activity).
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.
Time frame: 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.
Δ Sleep Efficiency (Percentage of Time Spent Asleep While in Bed)
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.
Time frame: 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.
Δ IL-6
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.
Time frame: 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.
Δ TNFɑ
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.
Time frame: 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.
| Milestone | Hypoxia 15% O2 - Sham (Room Air) 21% O2 | Sham (Room Air) 21% 02 - Hypoxia 15% O2 |
|---|---|---|
| Started | 8 | 6 |
| Completed | 8 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| mmol.min.L-1 | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ Mean AUC (Area Under the Curve) Plasma [Glucose] | -17.7 ± 237.7 | 54.9 ± 226.1 |
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.
| kg | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ Body Mass | 0 ± 0.9 | -0.7 ± 1 |
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.
| min | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ Total Minutes of Physical Activity (Light, Moderate, Moderate to Vigorous Physical Activity). | 170 (103 to 237) | 183 (116 to 250) |
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.
| % of time spent asleep while | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ Sleep Efficiency (Percentage of Time Spent Asleep While in Bed) | 88 (79 to 97) | 86 (78 to 94) |
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.
| pg/mL | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ IL-6 | 1.06 (-1.66 to 3.78) | -0.55 (-2.08 to 0.98) |
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.
| pg/mL | Hypoxia 15% O2 | Sham (Room Air) 21% O2 |
|---|---|---|
| Δ TNFɑ | 0.66 (-2.06 to 3.38) | 0.61 (-1.75 to 2.97) |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypoxia 15% O2 | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Sham (Room Air) 21% O2 | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Total |
|---|---|
| Mean | 64 ± 9 |
| Sex: Female, Male(Participants) | Total |
|---|---|
| Female | 4 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Total |
|---|
| Region of Enrollment(Participants) | Total |
|---|---|
| United Kingdom | 13 |
| Height(m) | Total |
|---|---|
| Mean | 1.72 ± 0.09 |
| Mass(kg) | Total |
|---|---|
| Mean | 87.5 ± 14.6 |
| BMI(kg/m2) | Total |
|---|---|
| Mean | 29.7 ± 3.9 |
| HbA1c(mmol/mol) | Total |
|---|---|
| Mean | 61.1 ± 14.1 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The individual data set that is used for statistical analysis will be uploaded to our university repository and a DOI added to the paper upon publication.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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