Diabetes Mellitus, Type IINCT00554697
Diabetes Mellitus Type II and Tissue Oxygenation
An observational study of Diabetes Mellitus, Type II, run by The Cleveland Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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].
About this study
Official title: Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- tissue oxygenation, perioperative, outcome
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Mellitus Type II and Tissue Oxygenation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Kurz, The Cleveland Clinic
- Investigators
- Daniel I Sessler, M.D., Study chair, The Cleveland ClinicAndrea Kurz, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554697
- Sponsor's protocol ID
- 07-782
- Status last verified
- Mar 2017
- First submitted
- 6 Nov 2007
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period
- ClinicalTrials.gov ID
- NCT00554697
- Acronym / sponsor ID
- 07-782
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- tissue oxygenation, perioperative, outcome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes Mellitus Type II and Tissue Oxygenation
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Sessler, M.D. study chair
The Cleveland Clinic
Andrea Kurz, M.D. principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type II, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Mellitus Type II and Tissue Oxygenation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.