In the preceding Pre-POINT study a positive immune response was triggered in children aged between two and seven years with the aid of powdered insulin. The follow-up Pre-POINTearly study will now test whether this effect can be confirmed by giving very young children oral insulin, and whether type 1 diabetes can be prevented in the long term.
The insulin vaccination trial is a prime example of the excellent cooperation between universities and research institutes. Participants in the study are the Institute of Diabetes Research at the Helmholtz Zentrum München, the Paul Langerhans Institute Dresden at the Technische Universität Dresden, the German Center for Diabetes Research (DZD), the Technical University of Munich (TUM) and the Ludwig Maximilians University of Munich (LMU).
The new Pre-POINTearly vaccination study will treat children between the ages of six months and two years who carry a genetic risk of developing type 1 diabetes or have a family history of the disease, but who have not yet developed an autoimmune response. As in the preceding Pre-POINT study, the participants will take the insulin in powder form with their food every day for twelve months. The daily dose will be gradually increased from 7.5 mg to 67.5 mg. Medical examinations will be conducted at three-month intervals in order to monitor the general health of the participants. In the preceding study, oral insulin was shown to be well tolerated and safe. Hypoglycemia or other adverse effects such as allergies did not occur.
Why oral insulin as a vaccine?
When insulin is given orally, it is absorbed through the mucous membranes of the mouth and the intestines, and is split into smaller components during the digestive process. That is why oral insulin – in contrast to insulin that is injected – has no influence whatsoever on blood sugar levels. Instead it acts like a vaccine that trains the immune system. “The autoimmune response that causes type 1 diabetes in childhood is often initially directed at the insulin,” explains Prof. Anette-Gabriele Ziegler, Director of the Institute of Diabetes Research. The aim of the Pre-POINTearly study is therefore to build up immune tolerance to insulin and thus block the autoimmune process.” It is hoped that insulin in powder form will stimulate the growth of protective immune cells and thus prevent the destruction of insulin producing beta cells.
The working group headed by Professor Joerg Hasford of the Institute for Medical Information Processing, Biometrics and Epidemiology at LMU Munich is responsible for the methodology, data coordination and statistical evaluation of the Pre-POINT and Pre-POINTearly studies.
For more information without obligation, please contact the Institute of Diabetes Research Background:
Phone: 0800 – 828 48 68 (toll free in Germany)
Type 1 diabetes is becoming increasingly prevalent in children. Each year about six percent more children under the age of five are diagnosed than in the previous year. Often the autoimmune process, which precedes clinical symptoms of the disease, begins in the first two years of life. Early preventive steps must therefore be taken at this stage in a child’s development.
The Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches for the prevention and therapy of common major diseases such as diabetes mellitus and lung disease. To that end, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München has about 1,900 staff members and is headquartered in Neuherberg in northern Munich. It is a member of the Helmholtz Association, a community of 18 scientific-technical and medical-biological research centers with a total of about 31,000 staff members.http://www.helmholtz-muenchen.de/
The Institute of Diabetes Research (IDF) focuses on the origins and prevention of type 1 and type 2 diabetes as a long-term effect of gestational diabetes. The development of an insulin vaccine to prevent type 1 diabetes is a high-priority project at the institute. In large-scale, long-term studies, the IDF examines the relationship between genetics, environmental factors and the immune system in the pathogenesis of type 1 diabetes. Using the data obtained from the birth cohort study BABYDIAB, which was established in 1989 as the first prospective diabetes birth cohort worldwide, both high-risk genes and antibody profiles can be identified. Based on this data, predictions can be made about the onset and development of type 1 diabetes which will alter both the classification and time of diagnosis of the disease. The IDF is part of the Helmholtz Diabetes Center (HDC).
The Paul Langerhans Institute Dresden of the Helmholtz Center Munich at the University Clinic Carl Gustav Carus of TU Dresden (PLID) was founded in 2009 in the course of the establishment of the German Center for Diabetes Research e.V. In January 2015, the PLID also became a satellite institute of the German Research Center for Environmental Health in Munich. Since its establishment in 2009, eight professors and five independent group leaders could be recruited to join the PLID. This was possible due to intense collaborations between the PLID, the Center for Regenerative Therapies Dresden (CRTD), the Faculty of Medicine and the University Clinic Carl Gustav Carus and is also justified by the outstanding reputation of the Dresden Diabetes Research. The scientific focus of the PLID is on the molecular cell biology, the development, regeneration and protection of the beta cells of the islets of Langerhans in the pancreas for the therapy and the prevention of Type-1 and Type-2-Diabetes.
The German Center for Diabetes Research (DZD) is a national association that brings together experts in the field of diabetes research and combines basic research, translational research, epidemiology and clinical applications. The aim is to develop novel strategies for personalized prevention and treatment of diabetes. Members are Helmholtz Zentrum München – German Research Center for Environmental Health, the German Diabetes Center in Düsseldorf, the German Institute of Human Nutrition in Potsdam-Rehbrücke, the Paul Langerhans Institute Dresden of the Helmholtz Zentrum München at the University Medical Center Carl Gustav Carus of the TU Dresden and the Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the Eberhard-Karls-University of Tuebingen together with associated partners at the Universities in Heidelberg, Cologne, Leipzig, Lübeck and Munich.
In collaboration with the Institute of Diabetes Research at the Helmholtz Zentrum München, the Diabetes Research Group at the Technische Universität München (TUM) focuses on the causes of diabetes in children and young adults, early detection methods and prevention of the disease. It is also concerned with the development of the disease during pregnancy (gestational diabetes) as well as with risk factors for unborn babies and young infants associated with type 2 diabetes and obesity, and develops animal models for the study of diabetes.
The Institute for Medical Informatics, Biometry and Epidemiology (IBE) at the Ludwig-Maximilians-University of Munich covers the whole speciality from bioinformatics, epidemiology and public health research to biostatistics and clinical trials methodology in research, training and teaching. For over 20 years Prof. Dr. Joerg Hasford and his group mainly work on planning and statistical analysis of clinical trials as well as the forecasting research. The focus is on hemato-oncology and diabetes mellitus.
Scientific contact at Helmholtz Zentrum München:
Prof. Dr. Anette-Gabriele Ziegler, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Institute of Diabetes Research, Ingolstädter Landstr. 1, 85764 Neuherberg – Phone +49 89 3187 3405