 |
| | NEW ONSET TYPE 1 DIABETES WITHIN 6 WEEKS OF DIAGNOSIS, 12 TO 35 YEARS OF AGE (THYMOGLOBULIN) Basic Eligibility Criteria: New Onset Type 1 Diabetes within 6 weeks of diagnosis, 12 to 35 years of age Drug Name: Thymoglobulin® Study Name: Effect of Antithymocyte Globulin (ATG) on Preserving Beta-Cell Function in New Onset Type 1 Diabetes Mellitus Study Sponsors: National Institute of Allergy and Infectious Disease (NIAID) (Immune Tolerance Network Protocol ITN 028AI) Principal Investigator: Stephen E. Gitelman, M.D. - Director, Pediatric Diabetes Program, UCSF Who can sign up for this study? o New onset type 1 diabetics, within 6 weeks of diagnosis o 12 to 35 years of age What is this study about? The purpose of this research study is to see if 4 doses of the experimental medication Thymoglobulin® given to people with recent onset type 1 diabetes will help save the remaining beta cells in the pancreas from further destruction by the immune system. Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time of type 1 diabetes diagnosis, 60% to 85% of the diabetic person’s beta cells have already been destroyed. However, between 15% and 40% of these cells remain and are still able to produce insulin. Treatment that slows the destruction of additional beta cells may be able to decrease a patient’s reliance on insulin injections and improve their quality of life. Thymoglobulin s a man-made antibody that has been approved by the Food and Drug Administration (FDA) to treat and prevent organ transplant rejection. Thymoglobulin acts on white blood cells, known as T cells, some of which are responsible for the destruction of beta cells in type 1 diabetes. This study will test whether the antibody can destroy the destructive T cells while permitting new ones to grow in their place that will not attack the remaining functional beta cells. What will happen in this study? If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at UCSF for a Screening visit where you can expect:
All participants will have 12 visits over the first 6 months of the study, then additional visits every 3 months until the end of the study. Assessment of diabetes control, insulin use and blood collection will occur at every visit. In addition, at some visits, participants will undergo physical exams and mixed-meal tolerance testing, which involves drinking a special protein drink and having blood specimens taken over a 2- to 4-hour period. All participants in the study will undergo “intensive diabetes management.” You will be expected to perform blood glucose testing at least 4 times a day and take insulin to keep your blood glucose within the target range as needed. You will be asked to discuss your blood glucose control with the study team every two weeks, and the team will work in conjunction with your regular diabetes provider to advise you on how to optimize your diabetes management plan so as to achieve the target goals. How long will this study last? 2 years If your beta cells are still producing insulin at the end of this time, you will be asked if you would like to continue to be followed for up to 5 years. Reimbursement: Participants will receive compensation for participating in the study. In addition, parking at UCSF for the time of study visits will be paid for, and if you live more than 50 miles from UCSF, travel costs will be covered by the study. For more information please contact: Marcia Wertz, RN at 415-514-3597, or Marcia.Wertz@ucsf.edu | Related Items |
