The Effects of Normobaric Hypoxia on Blood Glucose Levels.
This study is not yet open for participant recruitment.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Mike O'Callaghan Federal Hospital
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302782
First received: February 17, 2011
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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).
| Condition |
|---|
|
Glucose |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Effects of Normobaric Hypoxia on Blood Glucose Levels. |
Resource links provided by NLM:
Further study details as provided by Mike O'Callaghan Federal Hospital:
Primary Outcome Measures:
- Change in glucose levels at altitude [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 25 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302782
Contacts
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC | 7026532756 | jill.teixeira@nellis.af.mil |
| Contact: Travis Russell, M.D. | 7026532775 | travis.russell@nellis.af.mil |
Locations
| United States, Nevada | |
| Mke O'Callaghan Federal Hospital | Not yet recruiting |
| Nellis AFB, Nevada, United States, 89191 | |
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 7026532756 jill.teixeira@nellis.af.mil | |
| Principal Investigator: Travis Russell, M.D. | |
| Sub-Investigator: Paul Crawford, M.D. | |
| Sub-Investigator: Melissa May, M.D. | |
| Sub-Investigator: Matthew Taranto | |
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
| Principal Investigator: | Travis Russell, M.D. | Mike O'Callaghan Federal Hospital/Nellis Air Force Base |
More Information
No publications provided
| Responsible Party: | Mike O'Callaghan Federal Hospital |
| ClinicalTrials.gov Identifier: | NCT01302782 History of Changes |
| Other Study ID Numbers: | FWH20110021H |
| Study First Received: | February 17, 2011 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mike O'Callaghan Federal Hospital:
|
Altitude Glucose |
Additional relevant MeSH terms:
|
Anoxia Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013