The Effects of Normobaric Hypoxia on Blood Glucose Levels.

NCT01302782 | Withdrawn

• 1 other identifier: FWH20110021H
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Glucose

Keywords

Altitude; Glucose

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We are recruiting male and female patients (MOFH personnel and DoD beneficiaries) whom are at least 18 years of age from the Nellis Air Force Base population.

You may qualify if:

• Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
• males with a BMI \< 25; 5 males with a BMI \> 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).
• females with a BMI \< 25; 5 females with a BMI \> 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).

You may not qualify if:

• 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
• males and/or females, at least 18 years of age, that are type 2 diabetics (MOFH personnel and DoD beneficiaries).
• Pulmonary disease.
• History of claustrophobia.
• Pregnant or breast feeding.
• Non-English speaking.
• Physical inability to wear/use the ROBD2

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Officials

• Travis Russell, M.D.

  Mike O'Callaghan Federal Hospital/Nellis Air Force Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 24, 2011
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11