The Effect of Hypoxia on Type 2 Diabetes and Weight Loss

NCT05147116 | Completed Results

• 1 other identifier: 009AS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (5)

• Δ Body Mass

  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).

  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)

  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

  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

  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.

Study Arms (2)

Hypoxia 15% O2

EXPERIMENTAL

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

Other: Sleeping in a tent

Sham (room air) 21% 02

SHAM COMPARATOR

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

Other: Sleeping in a tent

Interventions

Sleeping in a tent OTHER

Participants will spend 10 consecutive nights of sleeping in a tent

Hypoxia 15% O2; Sham (room air) 21% 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and post-menopausal women with T2DM (as diagnosed with the WHO criteria).

You may not qualify if:

• Individuals with contraindications to hypoxic exposure (e.g. obstructive sleep apnoea, extant cardiac conditions or on medications such as SGLT2 inhibitors or PPAR antagonists).

Sponsors & Collaborators

• University of Portsmouth: lead
• Bournemouth University: collaborator
• University College, London: collaborator
• University of Cambridge: collaborator
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Anthony Shepherd

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Anthony Shepherd
• Organization: University of Portsmouth

ant.shepherd@port.ac.uk

02392845289

Study Officials

• Anthony Shepherd, PhD

  University of Portsmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will undergo both the hypoxia and sham conditions and will be blinded to the conditions in which they are in.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Physical Activity, Exercise and Health

Model Details: Single blind, randomized, balanced, crossover design study

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 7, 2021
• Study Start: February 17, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication - no plan to remove.
• Access Criteria: Dataset is open access from the URL below.

Locations

GB (1)