TerminatedNot Applicable

Diabetes Mellitus Type II and Tissue Oxygenation

Stopped: Unable to recruit subjects

60 participantsStarted 2007-11

Plain-language 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.

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diabetes Mellitus Type II and Tissue Oxygenation

Timeframe: 5 years

Trial details

NCT IDNCT00554697

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-11

View on ClinicalTrials.gov More Diabetes Mellitus, Type II trials