The Diabetes Center of Excellence at Shands at UF

Numerous clinical trials are currently being conducted at the University of Florida which may lead to the marketing of a new drug therapy or the development of a new treatment that will help those with diabetes lead healthier lives.

People participate in clinical trials for a variety of reasons. However, all clinical trials are rigorously designed and researchers follow strict ethical and scientific principles to make sure participants are protected and valid results are produced.

To assure this, the study's investigator must write a plan, called a protocol, of how the study will be run. This protocol is reviewed by the organization sponsoring the study as well as the Institutional Review Board of the University of Florida. The IRB members seek to ensure that participants will not be exposed to unreasonable or unethical risks.

You do not need referral by your physician to participate in any University of Florida clinical trial. However, there generally are certain health criteria which must be met. If, after being evaluated by medical staff, it is determined that you are eligible, it is up to you to decide if you wish to participate.

Listed below are clinical trials currently being conducted in both pediatric and adult endocrinology and other departments with an interest in diabetes research. After the description is a contact name and number that you may call to receive further information.

If you do not live in the North Central Florida area, you may reach any of the contacts listed below by first dialing 1-800-749-7424 and asking for the individual named.

Studies for People with Type 1 Diabetes
(insulin-dependent or IDDM)

Inhaled Insulin Study

This study is a Phase 3 study examining the efficacy and safety of inhaled insulin in the treatment of diabetes mellitus. Presently, approximately 90 subjects have been in an extended study of inhaled insulin for 18 to 28 months. The study has been extended for one more year and currently 14 children ages 7-16 are enrolled. Participants will receive a measured physical exam, EKG and chest x-ray. An interview regarding family history and health, blood pressure measurements sample will be taken. Confidentiality of all information will be protected.

Contact David Matthews, RN, Study Coordinator at (352) 334-1390
or email at matthdg@peds.ufl.edu

Diabetes Prevention Trials - Type 1 (see link above)

Type 1 Diabetes TrialNet (see link, TrialNet, above)

Type 1 Diabetes Genetics Consortium (see link above)

The PANDA Study (see link above)

The TEDDY Study (see link above)

GoKinD Study (Genetics of Kidneys in Diabetes)

This study is focused on discovering the genes that cause kidney disease in people with diabetes. Participants must have been diagnosed with type 1 diabetes before age 31 and have clinical diagnosis of kidney disease, including proteinuria, dialysis or kidney transplant. An interview regarding family history and health, blood pressure measurements and a blood sample will be taken. Compensation is available. Confidentiality of all information is protected.

Contact Karen Brezner, Study Coordinator at (352) 846-2231
or email at breznka@medicine.ufl.edu

Studies for either Type 1 or Type 2 Diabetes

Myotonic Dystrophy

The main purpose of this research is to see if the insulin resistance in myotonic dystrophy can be improved by treatment with a drug called rosilgitazone. The second purpose is to see if rosglitzone treatment improves some of the symptoms and blood tests in the condition. Participants must be 18 years or older with myotonic dystrophy and will receive interview for medical history, bloodwork and will be expected to return for six visits over a 34 week period. Compensation is available.

For more information, contact Karen Brezner, Study Coordinator
at (352) 846-2231 or email at breznka@medicine.ufl.edu

Studies for People with Type 2 Diabetes
(non-insulin dependent or NIDDM)

Bari 2 Study

This large scale study will study the effects of several interventions on patients with diabetes and coronary heart disease. Participants must be between the ages of 25-60 and be diagnosed with type 2 diabetes. An interview regarding family history and health, a physical exam and testing for coronary artery disease. The patient will be followed for five years with revisits scheduled 3-6 months apart. There is no compensation but the possibility of insurance reimbursement.

For more information, contact Karen Brezner, Study Coordinator at (352) 846-2231 or email at breznka@medicine.ufl.edu

Long-Acting Insulin Study

This study's primary objective is to determine whether glycemic control as measured by HbAlc is different between insulin glargine and insulin NPL 75/25 at supper when added to patients who fail an oral combination of a sulfonylurea and metformin. Participants must have been diagnosed with type 2 diabetes for at least one year, between the ages of 18-79 years, have an HBAlc of between 8 and 11% and been treated continuously with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months.

For more information, contact Karen Brezner, Study Coordinator at (352) 846-2231 or email at breznka@medicine.ufl.edu

ANTHEM Study

The purpose of this 40 week study is to compare the effects of two drugs on patients with high lipid levels (hyperlipedemia). Participants must be between the ages of 18-70, have type 2 diabetes and must present with elevated triglyceride levels with a low HDL level. Compensation will be paid at each visit and eligible participants will receive a physical exam, EKG and laboratory testing.

For more information, contact Karen Brezner, Study Coordinator at (352) 846-2231 or email at breznka@medicine.ufl.edu

Kidney Disease Study

Participants in this study must be between the ages of 18-60 with type 2 diabetes. The objective of the study is to test the effect of the anti-glyycation agent (EXO-226) on renal dysfunction in albuminuric diabetic patients. Eligible participants will receive a physicial assessment, lab tests, and study medications. Compensation is available.

For more information, contact Karen Brezner, Study Coordinator at (352) 846-2231 or email at breznka@medicine.ufl.edu

Studies for Youth with Type 2 Diabetes
(none currently)