Max McGee Research Center - Research Studies
The following are ongoing research studies related to Type 1 Diabetes, in which individuals or families can participate. All studies conducted through the Max McGee Center are also listed on the ClinicalTrials.gov website.
Current Studies
Type 1 diabetes is a disease that happens when the pancreas (a gland behind the stomach) makes little or no insulin. Insulin is a hormone (chemical) released by a pancreatic beta cell which is needed for uptake of sugars (e.g. glucose, the main type of sugar in the blood) into body tissues for energy production. This energy fuels the body’s functions. Without insulin, too much glucose stays in the blood. Over time, increased glucose in the blood can lead to serious problems with the heart, kidneys, nerves, and eyes.
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person’s own immune system, directed by genetic and environmental factors play a major role in its development. The Max McGee National Research Center for Juvenile Diabetes, affiliated with the Medical College of Wisconsin and Children’s Wisconsin, is using a genetic approach to try to better understand the step-by-step mechanisms that cause the destruction of the beta cells of the pancreas leading to diabetes. The more information scientists have, the better they can design studies to find possible treatment and prevention options for type 1 diabetes. But first, this study, Genetics of Autoimmunity in Type 1 Diabetes Mellitus may help us find more information about the disease.
Does someone in your family have type 1 diabetes?
If so, your family may be eligible to participate in our study to help us learn more about the causes of type 1 diabetes. If you would like to help, here’s how to get started:
We are looking for families which include a child with type 1 diabetes, brothers, sisters and parents. Adults with type 1 diabetes, their children and spouses are also needed.
If your family fits either description, you may complete our screening questionnaire. You can download, print and complete the paper copy. Type 1 Diabetes Family Study Screening Questionnaire (PDF)
Return completed form by mail or fax to:
Family Study Coordinator
Max McGee Diabetes Research Center
Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
(414) 955-6663 (fax)
Once we receive your completed form, a study coordinator will contact you and provide more information about study participation OR you may contact study coordinator at (414) 955-4903 or T1dinfo@mcw.edu
Participation involves:
- A visit to Children’s Wisconsin by immediate family members to donate a blood sample for genetic analysis and measurement of immune system responses associated with type 1 diabetes
- Completion of a family medical history questionnaire
- Measurement of height and weight
- Possible follow-up: "at-risk" family members may be asked to give an additional blood sample once or twice a year for up to 10 years
If you don’t have type 1 diabetes in your family, you can still help.
We need healthy kids and adults to participate as “control subjects” or a comparison group. Control subjects provide an essential comparative sample to diabetic subjects. Answer the following questions to find out if you are eligible to participate:
- Are you older than age 39?
- Have you ever been told that you have diabetes of any kind?
- Do you have any close relatives (parents, brothers/sisters, aunts/uncles, nieces/nephews or grandparents) with type 1 diabetes?
- Do you have any other known autoimmune diseases or conditions?
(Includes: Addison’s Disease, Ankylosing Spondylitis (Marie-Strümpell Disease), Anterior Uveitis (Iritis), Autoimmune Polyendocrine Syndrome (APS), Autoimmune Thyroid Disease (such as Graves’ Disease or Hashimoto’s), Celiac Disease (gluten intolerance), Inflammatory Bowel Disease (Crohn’s Disease or Ulcerative Colitis), JRA (Juvenile Rheumatoid Arthritis), Multiple Sclerosis (MS), Myasthenia Gravis, Psoriasis, Rheumatoid Arthritis, Systemic Lupus.)
If you answered No to all of these questions, you may be eligible to participate.
Participation involves a visit to Children’s Wisconsin, answering some medical and family history questions and giving a blood sample of 50 ml (about 3 Tablespoons + 1 teaspoon). You will receive a gift certificate for your time and travel.
Please contact a study coordinator at (414) 955-8486 or jkramer@mcw.edu to participate.
Participation in Collaborative Studies
Evidence supports that most subjects who develop Type 1 diabetes (T1D) possess autoimmunity towards β-cells for years prior to clinical onset. Presently, it is impossible to precisely predict who will develop T1D or when they will clinically present. Siblings of T1D probands have an approximately 6% probability of progression to T1D. Therefore, the temporal analyses of samples from siblings of T1D probands is crucial for gaining an understanding of disease initiation and progression. The study of this population is also crucial to understanding mechanisms that prevent T1D progression within the context of high genetic risk. The Max McGee Research Center for Juvenile Diabetes Family Genetics Study is a longitudinal study aimed at gaining new insight into the mechanisms that govern progression to and protection from T1D progression. Subjects are enrolled through Children’s Wisconsin and return for yearly visits. The Children's Wisconsin Diabetes Clinic is a large program that cares for >1,600 pediatric diabetes patients on an annual basis; the majority of these (>91%) are T1D patients.
Presently the study includes approximately 500 families with T1D. In most cases, the parents, the pediatric new onset T1D proband, and the unaffected siblings have been enrolled. Eligible subjects are >2 years of age at the time of enrollment and are followed for a duration of up to 10 years. This study has been ongoing for nearly 15 years and to date we have collected samples and clinical data from >2,200 subjects, with longitudinal analyses of approximately 600 siblings. All subjects have been HLA typed by nucleotide sequencing of the second exons of HLA-DQA1 and HLA-DQB1. At each annual visit, serum, plasma, cryopreserved leukocytes, and DNA, have been collected and antibody titers have been measured (INS, ZnT8, GAD, IA2). Presently, the study encompasses >65 non-diabetic subjects that have seroconverted to autoantibody positivity and >500 persistently autoantibody negative subjects. To date, progression to T1D has been captured in 15 subjects. The study also includes age-, sex- and ethnically-matched unrelated healthy controls, as well as Type 2 diabetes controls.
We recognize that collaboration with investigators at other institutions is essential to our mission of understanding T1D pathogenesis and to our goal of identifying biomarkers of T1D progression or non-progression. As such, we have, and will continue to grant investigators at other institutions access to study samples through collaborative arrangements. Access is predicated on:
- scientific merit of the proposed analyses, in particular an assessment of the likelihood of scientific advancement over the risk of using samples that are difficult to replace;
- sample availability and the ability to address the scientific question with appropriate control and statistical rigor;
- an agreement that all analyses will be conducted in a blinded manner;
- an understanding that data generated will be integrated with other analyses conducted on the same subjects with the objective of attaining a deeper understanding of progression/non-progression;
- compliance with all institutional policies and IRB regulations at the collaborative sites involved.
Inquiries should be made directly with Martin Hessner, PhD (mhessner@mcw.edu). All collaborative arrangements will be reviewed/approved by a panel of McGee Center faculty.
Type 1 Diabetes TrialNet is a global network of researchers and immunology experts dedicated to the study, prevention, and early treatment of type 1 diabetes. It is supported by the Department of Health and Human Services National Institutes of Health, Juvenile Diabetes Research Foundation International, and the American Diabetes Association.
The Max McGee Diabetes Research Center* is an Affiliate Site for the Natural History Study of the Development of Type 1 Diabetes. This study screens relatives of people with type 1 diabetes to find out if family members are at risk for developing diabetes.
The purpose of this study is to gain more information about how type 1 diabetes develops. Then studies can be designed for people who are at risk for developing type 1 diabetes or have just been told they have type 1 diabetes. The more information scientists have, the better they can design studies to find possible treatment and prevention options for type 1 diabetes. But first, the Natural History Study may help find more information about the disease.
TrialNet also has prevention studies and intervention studies. If you are enrolled in the Natural History Study and learn you are at risk for developing type 1 diabetes, you may qualify to be enrolled in a prevention study. If you develop diabetes during the study, you may qualify for an intervention study.
Inclusion Criteria
You may be able to take part in this study if you are:
- Between 1 and 45 years old and have a brother, sister, child or parent who has been diagnosed with type 1 diabetes
- or - - Between 1 and 20 years old and have a cousin, niece, nephew, aunt, uncle, half sibling, or grandparent who has been diagnosed with type 1 diabetes
Exclusion Criteria
You may not be able to participate if you:
- Have diabetes already
- Have a previous history of being treated with insulin or oral diabetes medications
- Are currently using systemic immunosuppressive agents (topical or inhaled agents are acceptable
- Have any known serious diseases
You may contact the study coordinator for more information:
(414) 955-4903 | T1dinfo@mcw.edu
TrialNet Study Coordinator
Max McGee Diabetes Research Center
Children’s Wisconsin/ Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
Type 1 Diabetes Research Studies at TrialNet Brochure (PDF)
Participation involves:
- A visit to Children’s Wisconsin to donate a blood sample which will be screened for diabetes-related antibodies
- Answering a few medical history questions
- Possible follow-up: individuals with a positive antibody result may be offered further testing to determine their risk of developing diabetes over the next 5 years. You would need to give additional permission to participate in the next stage of testing.
Sponsors:
- National Institute of Diabetes & Digestive & Kidney Disease (NIDDK)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Child Health and Human Development (NICHD)
- National Center for Research Resources (NCRR)
- Juvenile Diabetes Research Foundation International (JDRF)
- American Diabetes Association (ADA)
*The Max McGee Diabetes Research Center is affiliated with the Medical College of Wisconsin and Children’s Wisconsin.