NCT01361971

Brief Summary

Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. This study has the potential to yield new and important insights into the insulin resistance in obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

May 24, 2011

Last Update Submit

September 17, 2013

Conditions

ObesityType 2 Diabetes

Keywords

Insulin resistanceInflammationHypoxia

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Using Hyperinsulinemic clamp

    1 year

Secondary Outcomes (1)

  • Hypoxia and inflammatory markers

    1 year

Interventions

Hyperbaric Oxygen TreatmentPROCEDURE

Participants will undergo 4 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere, during this time, patients will be treated with 100% Oxygen delivered via a hood system.

Eligibility Criteria

Age45 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese men with and without type 2 diabetes aged 45-70
  • Lean men without type 2 diabetes aged 45-70

You may not qualify if:

  • smokers
  • claustrophobic
  • sleep apnoea
  • blood donor
  • exercise more than 2 times per week
  • under certain medications eg: bleomycin,corticosteroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Adelaide

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceInflammationHypoxia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesSigns and Symptoms, Respiratory

Study Officials

  • Leonie K Heilbronn, Phd

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 27, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

AU(1)