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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
Information provided by (Responsible Party):
Andrea Kurz, The Cleveland Clinic

Brief Summary:
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 or disease
Diabetes Mellitus, Type II

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 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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period
Study Start Date : November 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Diabetes Mellitus Type II and Tissue Oxygenation [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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].

Information from the National Library of Medicine

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

Sponsors and Collaborators
The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic

Responsible Party: Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00554697     History of Changes
Other Study ID Numbers: 07-782
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Andrea Kurz, The Cleveland Clinic:
tissue oxygenation

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