Diabetes Mellitus Type II and Tissue Oxygenation
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|ClinicalTrials.gov Identifier: NCT00554697|
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : November 7, 2007
Last Update Posted : March 16, 2017
|Condition or disease|
|Diabetes Mellitus, Type II|
The goal is to test the hypothesis that: 1) perioperative subcutaneous oxygenation (PsqO2) is lower in diabetic than non-diabetic patients; and, 2) supplemental oxygen provides less benefit in diabetic than non-diabetic patients.
We propose a prospective case-control study which will include 30 Type II diabetics matched for age, sex, and race to 30 non-diabetic controls. Patients will be preselected from a population undergoing abdominal surgery and given supplemental inspired oxygen of 30 - 80% to PaO2 of approximately 150mmHg and/or 300mmHg at three timepoints in the perioperative period. PsqO2 will be measured with an IV-sized probe inserted through a small incision made in the skin. Data will be recorded and analyzed using unpaired two tailed t-test, Wilcoxon's ranked sum test, or repeated-measures analysis of variance (ANOVA) test as appropriate.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- Diabetes Mellitus Type II and Tissue Oxygenation [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554697
|Study Chair:||Daniel I Sessler, M.D.||The Cleveland Clinic|
|Principal Investigator:||Andrea Kurz, M.D.||The Cleveland Clinic|