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Diabetes Mellitus Type II and Tissue Oxygenation

This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00554697
First received: November 6, 2007
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to determine whether diabetics have decreased amounts of oxygen in the skin compared to non-diabetic individuals, and if the amount of oxygen in the skin changes when given more oxygen to breathe around the time of surgery. To do this, the investigators will be measuring the amount of oxygen in the skin of diabetic and non-diabetic individuals who will be undergoing abdominal surgery lasting 2-4 hours. These measurements will be taken at three different times.


Condition
Diabetes Mellitus, Type II

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Enrollment: 60
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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 timpoints 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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will include 30 patients who have more than a five-year history of insulin-dependent type-2 diabetes mellitus and 30 non-diabetic patients

Criteria

Inclusion criteria:

We will include 30 patients who have more than a five-year history of insulin-dependent type-2 diabetes mellitus and 30 non-diabetic patients meeting the following criteria:

  • 35 - 65 yrs old
  • BMI < 30
  • ASA class I - III
  • Abdominal surgery scheduled to last between 2- 4 hours

For Non-diabetic group:

previous BMP within the last year demonstrating glucose < 126mg/dL

For Diabetic group:

  • DMII defined as fasting plasma glucose of > 126 mg/dL at time of diagnosis, now requiring insulin
  • At least one diabetes associated vasculopathy: coronary artery disease, diabetic nephropathy, hypertension, diabetic retinopathy, diffuse neuropathy, peripheral vascular disease, or a history of stroke

Exclusion Criteria:

  • Pregnant
  • Immunocompromised: HIV/AIDS, on immunosuppressant therapy for any reason, or post-organ transplantation.
  • Infection or fever, or on glucocorticoids
  • Malignancy currently requiring radiation or chemotherapy
  • Liver or renal failure
  • Pancreatic insufficiency, dysautonomia, thyroid disease, Raynaud's syndrome, pathologic Allen-test, or any coagulopathies
  • Respiratory disease affecting ability to reach PaO2 of 300mmHg: COPD, emphysema, cystic fibrosis, asthma, pneumonia, PE
  • Smoker within the past 6 months or current alcohol abuse
  • Allergy to local anesthetic
  • For diabetics: DMI, other specific subtype, and gestational diabetics
  • We will also exclude patients with epidural catheter, to avoid the influence of regional anesthesia on tissue oxygenation [37, 38].
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554697

Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Andrea Kurz, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00554697     History of Changes
Other Study ID Numbers: 07-782
Study First Received: November 6, 2007
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
tissue oxygenation
perioperative
outcome

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013