The Effects of Normobaric Hypoxia on Blood Glucose Levels.

Glucose Clinical Trial

Official title:

The Effects of Normobaric Hypoxia on Blood Glucose Levels.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01302782
• Other study ID #: FWH20110021H
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2011
• Last updated: November 21, 2013
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Mike O'Callaghan Federal Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to observe whether there is a change in blood glucose levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric hypoxia (short term low oxygen levels at normal ambient air pressure).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (non-diabetics):

• Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB

• 5 males with a BMI < 25; 5 males with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).

• 5 females with a BMI < 25; 5 females with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (non-diabetics):

• History of abnormal fasting glucose.

• Pulmonary disease.

• Any medications that change glucose control to include systemic steroid and diabetic medications.

• History of claustrophobia.

• Pregnant or breast feeding.

• Non-English speaking.

• Physical inability to wear/use the ROBD2

Inclusion Criteria (diabetics):

-5 males and/or females, at least 18 years of age, that are type 2 diabetics (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (diabetics):

• Pulmonary disease.

• History of claustrophobia.

• Pregnant or breast feeding.

• Non-English speaking.

• Physical inability to wear/use the ROBD2

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Glucose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mike O'Callaghan Federal Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose levels at altitude	Subjects will be placed on a Reduced Oxygen Breathing Device (ROBD2) to simulate 3 different altitudes at three separate and distinct time periods (ground, 8,000 feet and 12,000 feet) then obtain c-peptide and 2-hour OGTT to determine blood glucose changes during acute normobaric hypoxia.	1 year	No