Insulin Sensitivity During Hyperbaric Oxygen Compared to Hyperbaric Air

NCT03138746 | Completed

• 1 other identifier: R20160801
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this study is to investigate the relationship between pressure and oxygen in producing this effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure of oxygen required? Aims:

1. 1.To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air at the same pressure as HBO.
2. 2.To examine mechanisms underpinning the increase in insulin sensitivity following HBO.

Conditions

Diabetes Mellitus, Type II; Insulin Resistance

Keywords

hyperbaric oxygenation; insulin sensitivity; human; inflammation

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  As measured by the glucose infusion rate during the steady-state phase of the hyperinsulinaemic euglycaemic clamp on day 2

  Baseline to Day 2

Secondary Outcomes (1)

• change in inflammatory cytokines

  Day 1 and 2

Study Arms (2)

HBO

On day 2, the participant will undergo a 2-hour hyperbaric exposure breathing 100% oxygen

Procedure: HBO

Hyperbaric air

On day 2, the participant will undergo a 2-hour hyperbaric exposure breathing air

Procedure: Hyperbaric air

Interventions

HBO PROCEDURE

Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a "hood" supplying high flow oxygen for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes

HBO

Hyperbaric air PROCEDURE

Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a "hood" supplying high flow air for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes

Hyperbaric air

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Men with T2DM, n=40 (numbers are based on power analysis of previous studies)
• Normal to obese weight (BMI 25-40 kg/m2)
• Age \> 40 (no specific upper age limit)
• All participants will attend the Hyperbaric Medicine Unit to be assessed by a hyperbaric physician (DW) to determine fitness to enter the hyperbaric chamber the standard clinical criteria of the Hyperbaric Medicine Unit will be used

You may not qualify if:

• use of prescribed or non-prescribed medications which may affect glucose homeostasis (eg steroids)
• uncontrolled asthma, current fever, upper respiratory infections
• individuals who regularly perform high intensity exercise (\>2 week)
• current intake of \> 140g alcohol/week
• current smokers of cigarettes/cigars/marijuana
• current intake of any illicit substance
• experience claustrophobia in confined spaces
• has donated blood within past 3-months
• has been involved in any other study within the past 3-months
• unable to comprehend study protocol
• any other contraindication to HBO (eg Eustachian tube dysfunction making middle ear inflation ineffective)

Sponsors & Collaborators

• University of Adelaide: lead
• Royal Adelaide Hospital: collaborator

Study Sites (1)

Hyperbaric Medicine Unit, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (2)

• Wilkinson D, Chapman IM, Heilbronn LK. Hyperbaric oxygen therapy improves peripheral insulin sensitivity in humans. Diabet Med. 2012 Aug;29(8):986-9. doi: 10.1111/j.1464-5491.2012.03587.x.

  PMID: 22269009 BACKGROUND

• Wilkinson D, Nolting M, Mahadi MK, Chapman I, Heilbronn L. Hyperbaric oxygen therapy increases insulin sensitivity in overweight men with and without type 2 diabetes. Diving Hyperb Med. 2015 Mar;45(1):30-6.

  PMID: 25964036 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David C Wilkinson, FANZCA

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ARC Future Fellow

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: August 13, 2018
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)