N/A
N=14
The Effect of Hypoxia on Type 2 Diabetes and Weight Loss
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05147116 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Δ Mean AUC (Area Under the Curve) Plasma [Glucose] — -17.7; 54.9 mmol.min.L-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleeping in a tent (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Portsmouth
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Δ Mean AUC (Area Under the Curve) Plasma [Glucose] |
-17.7; 54.9 | — |
| SECONDARY Δ Body Mass |
0; -0.7 | — |
| SECONDARY Δ Total Minutes of Physical Activity (Light, Moderate, Moderate to Vigorous Physical Activity). |
170; 183 | — |
| SECONDARY Δ Sleep Efficiency (Percentage of Time Spent Asleep While in Bed) |
88; 86 | — |
| SECONDARY Δ IL-6 |
1.06; -0.55 | — |
| SECONDARY Δ TNFɑ |
0.66; 0.61 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Males and post-menopausal women with T2DM (as diagnosed with the WHO criteria).
Exclusion Criteria
- Individuals with contraindications to hypoxic exposure (e.g. obstructive sleep apnoea, extant cardiac conditions or on medications such as SGLT2 inhibitors or PPAR antagonists).
Data sourced from ClinicalTrials.gov (NCT05147116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.