Medical School

Diabetes, Endocrinology and Metabolism

Department of Medicine

Clinical Research

Research is a priority within the Division of Diabetes, Endocrinology and Metabolism. Highlighted studies are listed below by the focus of research, but please note that this list is not exhaustive and new studies are continuously developing. For more information on research within the Academic Health Center at the University of Minnesota, please visit the Health Sciences Research Corridor and the Clinical and Tranlational Science Institute websites.

Clinical Research Participation
What is a clinical trial?

A clinical trial is a research study that is conducted in a medical setting such as a clinic or hospital. It usually involves the testing of a new medication, treatment, or device that is not yet approved by the Food & Drug Administration (FDA) for routine use. Clinical trials can also explore new indications for drugs or treatments that are already FDA-approved and are carried out under strict guidelines with great attention to measures of safety. The purpose of a clinical trial is to obtain data regarding the safety and effectiveness of the medication or treatment for the use in which it is being tested. All medications and treatments in use today were first tested in a clinical trial.

For more information on clinical trials, please visit: ClinicalTrials.gov

How to enroll in a trial and what to expect?

The clinical trial investigators usually obtain permission from a volunteer's primary physician before a volunteer is enrolled. The investigators may interact with primary doctors but they do not replace them. Each volunteer is encouraged to maintain close communication with their primary physician regarding all aspects of the clinical trial. An interested volunteer is contacted by the research coordinator and a preliminary screening visit is scheduled to discuss the details of the study with the potential volunteer and determine if he/she is eligible to participate. The nurse or physician will explain the study and the procedures the volunteer will need to follow and answer any questions. This process is called informed consent and is essential before any volunteer is enrolled in any clinical trial. In addition, a full medical history is obtained and a physical exam and lab testing is done to make sure there are no contraindications for participation in the clinical trial. All clinical trials require a time commitment and study schedules vary depending on the individual study.

What are the rights of a clinical trial volunteer?

Participation in any clinical trial is voluntary. If you feel any pressure to volunteer for a clinical trial, you probably should not enroll. Volunteers can change their minds and withdraw from the study at any time. Any information obtained in a clinical trial remains confidential and is not shared unless authorized by the participant.
 

Type 1 Diabetes
Studies in Type 1 Diabetic Patients for Identical Twins Who Are Diabetic and Non-Diabetic

Principal Investigators: Luiza Caramori, MD, MS, PhD and Michael Mauer, MD

We have learned much about the structural basis for kidney dysfunction in type 1 diabetic patients over the past three decades of research in diabetic kidney disease at the Departments of Medicine (Division of Diabetes, Endocrinology and Metabolism) and Pediatrics (Pediatric Nephrology) at the University of Minnesota. Our studies of cultured skin cells from identical twins with type 1 diabetes will help to confirm the importance of genetic predisposition as a major factor in determining the risk of/or protection from diabetic kidney disease. In addition, skin cells from a diabetic person behave differently than cells from a non-diabetic person. These cells appear to have a “memory” of their diabetic environment or this difference may be genetic. By studying identical twins where one twin has type 1 diabetes , and the other twin is non-diabetic, we hope to continue to unravel these mysteries, and to better identify whether the cause of these observed differences is genetic, environmental or both.

Another purpose of this study is to collect samples of blood, DNA (the genetic material that defines our unique genes and characteristics), skin cells, and urine to be stored in a repository for use in future studies by us, our scientific collaborators, or other scientists who may want to use these samples for further research.

Although we are temporarily not recruiting identical twins for our study, we are always in search of identical twins who are discordant for type 1 diabetes (one has type 1 diabetes, the other one is non-diabetic).To reach us to answer any questions, or to provide us with your name and the most accurate contact information so that we can get in touch with you as soon as we secure additional funding for our twin study, contact Cathy Bagne, the project coordinator, at (612) 624-4688, or Karen Dalmacio at (612) 624-9871.

Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus

Principal Investigator: Elizabeth Seaquist, MD

The purpose of this pilot study is to see if the drug, naltrexone, should be studied more in people with Type 1 diabetes and hypoglycemia unawareness (a condition in which some people with diabetes do not have early warning signs of low blood sugar). Hypoglycemia unawareness occurs when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia, which can lead to more severe and dangerous hypoglycemia. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.

If you are interested in learning more about the study, please contact Anjali Kumar, PA-C at (612) 624-0470. Compensation and travel reimbursement are available.

Type 2 Diabetes
Accordion Eye Substudy, A substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study

Principal Investigator: Elizabeth Seaquist, MD

The ACCORD trial is a multi-center trial funded by the National Heart and Lung Institute designed to determine whether CVD event rates could be reduced in patients with type 2 diabetes at high risk for CVD events by intensively targeting three important CVD risk factors: hyperglycemia, dyslipidemia, and elevated blood pressure.

We are not currently recruiting for this study. More information about the trial can be obtained at www.accordtrial.org or by calling Mike Mech, study coordinator, at (612) 624-6101 to learn more about future opportunities.

The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND)

Principal Investigator: Elizabeth Seaquist, MD
Co-Investigator: Lisa Chow, MD

The purpose of this trial is to assess the effect of once-weekly administration of a glucagon-like peptide (GLP). Dulaglutide is an analog of the endogenous hormone glucagon-like peptide-1 (GLP-1). GLP-1 is a hormone that is synthesized in the L cells of the distal ileum and released in response to meals which acts to increase pancreatic insulin secretion in response to glucose, suppress glucagon secretion, and suppress appetite through a central effect. It is known that patients with type 2 diabetes have reduced secretion of GLP-1 in response to meals which contributes to reduced insulin secretion, increased glucagon secretion, and hyperglycemia. These abnormalities and perhaps the GLP-1 deficit itself may contribute to the 2 to 3-fold higher risk of fatal CV events in people with type 2 diabetes.

Recruitment for this study has ended.

The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)

Principal Investigator: Elizabeth Seaquist, MD
Co-Investigators: Bruce Redmon, MD; John Bantle, MD; Robert Jeffery, PhD

GRADE is a long-term study of different treatments for type 2 diabetes funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH). Type 2 diabetes is an epidemic that threatens to become the century's major public health problem and poses enormous human and economic challenges worldwide. Most people with diabetes eventually need 2 medications to control blood glucose levels. A major challenge is to determine which of the many possible drugs is the best choice among people already treated with metformin, the most commonly used diabetes drug. GRADE will determine which combination of two medications is best for glycemic control, has the fewest side effects, and is the most beneficial for overall health.

We are currently recruiting for this study. People with type 2 diabetes for 5 years or less who are taking no medications for their diabetes or who are taking only metformin may be eligible for GRADE. More information about the trial please visit the GRADE website or contact Mary Coe, Recruitment Coordinator at (612) 626-0143 for further details.

Obesity
Neural Correlates of Food Reward in American Indian Women

Principal Investigator: Tiffany R. Beckman, MD, MPH

Obesity has emerged as the dominant public health problem of the 21st century and is now epidemic among women. American Indians suffer disproportionately from obesity. This study will look at brain activity of American Indian women through the use of functional magnetic resonance imaging (fMRI) when they look at different kinds of food photographs. The purpose of this study is to see what happens in the reward centers of the brain when women look at different type of visual food cues. We will also examine the ability of medication (naltrexone) to suppress brain response to visual food cues. This is the first study using fMRI and an opioid and is the first study of this kind focusing specifically on American Indian women. The results will provide important data that will inform dietary interventions aimed at preventing and treating obesity. This study may also identify a promising pharmacologic treatment of obesity and overeating.

We are currently recruiting for this study. For additional information, please contact Tiffany R. Beckman, MD, MPH, Principal Investigator, at (612) 626-9329.

Kidney Disease
Pancreas or Islet Cell Transplantation And Diabetic Nephropathy In Man, Part Of Matas’ Studies Of Organ Transplantation In Animals And Man

Principal Investigators: Luiza Caramori, MD, MS, PhD and Michael Mauer, MD

We have been involved in diabetic kidney disease research for the past more than three decades and have learned much about the structural basis for kidney dysfunction in type 1 and type 2 diabetic patients. Our studies of cultured skin cells from patients who chose to have a pancreas transplant alone to cure their type 1 diabetes will help to confirm the importance of “metabolic memory” for the diabetic state as a major factor in determining the risk of/or protection from diabetic kidney disease. The purpose of this study is to learn whether or not a successful transplant will alter the behavior of skin cells grown in culture that have been affected by having been exposed previously to diabetes, before diabetes was cured by a pancreas or islet transplant. This work may be very important in our further understanding of how diabetes may cause damage to your eyes, kidneys, nerves, or blood vessels.

You are a possible participant if you meet the following: You have (or had) type 1 diabetes, and are planning on coming to the University of MN/Fairview for an appointment with transplant services to be seen for one of the following: 1) A pancreas transplant evaluation visit, 2) An islet cell transplant evaluation visit, 3) A follow-up visit for an already completed pancreas or islet cell transplantation (functioning or failed), or 4) if you have had a pancreas or islet cell transplant evaluation visit, but have not received a transplant yet. Another purpose of this study is to collect samples of blood, skin, and urine to be stored in a repository for use in future research.

To see if you are eligible for this study, please call the Transplant Center at (612) 625-5115, toll-free at 1 (800) 328-5465, or via email at transplant-center@fairview.org.

To contact us prior to or after your evaluation visit, please contact Karen Dalmacio at (612) 624-9871, or Cathy Bagne, the project coordinator, at (612) 624-4688.
 

Pancreas or Islet Cell Transplantation And Diabetic Nephropathy In Man, Part Of Matas’ Studies Of Organ Transplantation In Animals And Man

Principal Investigators: Luiza Caramori, MD, MS, PhD and Michael Mauer, MD

We have been involved in diabetic kidney disease research for the past more than three decades and have learned much about the structural basis for kidney dysfunction in type 1 and type 2 diabetic patients. Our studies of cultured skin cells from patients who chose to have a pancreas transplant alone to cure their type 1 diabetes will help to confirm the importance of “metabolic memory” for the diabetic state as a major factor in determining the risk of/or protection from diabetic kidney disease. The purpose of this study is to learn whether or not a successful transplant will alter the behavior of skin cells grown in culture that have been affected by having been exposed previously to diabetes, before diabetes was cured by a pancreas or islet transplant. This work may be very important in our further understanding of how diabetes may cause damage to your eyes, kidneys, nerves, or blood vessels.

You are a possible participant if you meet the following: You have (or had) type 1 diabetes, and are planning on coming to the University of MN/Fairview for an appointment with transplant services to be seen for one of the following: 1) A pancreas transplant evaluation visit, 2) An islet cell transplant evaluation visit, 3) A follow-up visit for an already completed pancreas or islet cell transplantation (functioning or failed), or 4) if you have had a pancreas or islet cell transplant evaluation visit, but have not received a transplant yet. Another purpose of this study is to collect samples of blood, skin, and urine to be stored in a repository for use in future research.

To see if you are eligible for this study, please call the Transplant Center at (612) 625-5115, toll-free at 1 (800) 328-5465, or via email at transplant-center@fairview.org.

To contact us prior to or after your evaluation visit, please contact Karen Dalmacio at (612) 624-9871, or Cathy Bagne, the project coordinator, at (612) 624-4688.

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  • Last modified on November 8, 2013