The Effect of Hypoxia on Type 2 Diabetes and Weight Loss

NCT ID: NCT05147116

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2023-01-30

Brief 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.

Detailed Description

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Hypoxia 15% O2

Participants will sleep in a tent for 10 nights in hypoxia.

Group Type: EXPERIMENTAL

Sleeping in a tent

Intervention Type: OTHER

Participants will spend 10 consecutive nights of sleeping in a tent

Sham (room air) 21% 02

Participants will sleep in a tent for 10 nights in normoxia.

Group Type: SHAM_COMPARATOR

Sleeping in a tent

Intervention Type: OTHER

Participants will spend 10 consecutive nights of sleeping in a tent

Interventions

Sleeping in a tent

Participants will spend 10 consecutive nights of sleeping in a tent

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bournemouth University

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Portsmouth

OTHER

Sponsor Role: lead

Responsible Party

Ant Shepherd

Senior Lecturer in Physical Activity, Exercise and Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Shepherd, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Portsmouth

Locations

Anthony Shepherd

Portsmouth, Hampshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

009AS

Identifier Type: -

Identifier Source: org_study_id