Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance | NCT01361971

Studies
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

NCT01361971

Sponsor

University of Adelaide

Status

Completed

Last Update Posted

Sep 19, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Obesity
Type 2 Diabetes

Interventions

Hyperbaric Oxygen Treatment

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

May 26, 2011

First Posted Date

May 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2013

Last Update Posted Date

Sep 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric Oxygen Treatment	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity	Using Hyperinsulinemic clamp	1 year

Secondary Outcomes

Measure	Description	Time Frame
Hypoxia and inflammatory markers	using IHC, qPCR, Western blot	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonie K Heilbronn, Phd	University of Adelaide	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Adelaide		Adelaide	South Australia		Australia

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance
D007249	Inflammation
D000860	Hypoxia

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided