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Archive - 06 - 2011
June 29, 2011 (Newswise) A recent study accepted for publication in The Endocrine Societys Journal of Clinical Endocrinology & Metabolism (JCEM) found that early, prolonged treatment with the diabetes drug metformin may prevent or delay the development of polycystic ovary syndrome (PCOS) in adolescence.PCOS affects 7 to 10 percent of women of childbearing age and is the most common cause of infertility, affecting an estimated 5 to 6 million women in the United States, according to The Hormone Foundation.PCOS often presents in adolescence, with irregular menstrual cycles, acne, or too much body hair, said the studys senior author, Lourdes Ibez, MD, PhD, professor of pediatrics at the University of Barcelona in Spain and lead author of the study. But we believe the critical years for PCOS development may be during childhood and puberty when excessive amounts of fat are stored. That excessive weight gain overexposes the ovaries to insulin, causing them to stop ovulating and start releasing male hormones, resulting in PCOS.In this study of 38 girls with low birth-weight and early puberty, researchers compared the efficacy of early versus late metformin treatment to prevent adolescent PCOS. A group of 19 8-year-old girls were treated with daily doses of metformin for four years. A second group of 19 girls waited five years before they began receiving daily doses of metformin at age 13 and then continued treatment for only one year. They found that early metformin therapy prevented or delayed the development of hirsutism, androgen excess and PCOS more effectively than late metformin treatment.Metformin, when given across the potentially critical window of puberty, may have the capacity to reprogram metabolism toward less abdominal and liver fat, Ibez concluded. In the years ahead, the focus of attention should shift from late treatment of PCOS and its complications, toward the early and large-scale prevention of PCOS, with measures such as diet, exercise and metformin in young girls.Other researchers working on the study include: Abel Lopez-Bermejo of Dr. Josep Trueta Hospital and Girona Institute for Biomedical Research in Spain; Marta Diaz of the University of Barcelona in Spain; Maria Marcos of Hospital de Terrassa in Spain; and Francis de Zegher of the University of Leuven in Belgium.The article, Early Metformin Therapy (Age 8-12yr) in Girls with Precocious Pubarche to Reduce Hirsutism, Androgen Excess and Oligomenorrhea in Adolescence, appears in the August 2011 issue of JCEM.
June 29, 2011 (Newswise) A computer-based diabetes simulation tool developed by University of Virginia researchers is now commercially available, thanks to a partnership with the Charlottesville-based medical research firm The Epsilon Group. The simulator is the only protocol that has been accepted by the U.S. Food and Drug Administration as an alternative to animal testing of Type 1 diabetes control strategies.Boris P. Kovatchev and Marc D. Breton of the U.Va. Center for Diabetes Technology developed the simulator in collaboration with Claudio Cobelli and Chiara Dalla Man at the University of Padova, Italy. The U.Va. Patent Foundation granted Epsilon, a division of Medical Automation Systems Inc., an exclusive license to the technology in April."It takes a tremendous amount of time and resources to conduct animal testing for clinical trials, often only to find that a treatment doesn't work," said Miette H. Michie, interim executive director and CEO of the U.Va. Patent Foundation. "Through their innovative diabetes simulator, Drs. Kovatchev and Breton and their collaborators have provided an FDA-accepted substitute for animal trials, allowing effective treatments to reach the market and start impacting patients much sooner."The simulator uses a software algorithm to model the human metabolic system. Based on patient data from 300 children, adolescents and adults with Type 1 diabetes, the algorithm uses 26 different parameters to mimic human metabolism at the individual level, through several distinct patient profiles. Within these individual profiles, variables such as diet, exercise behavior and insulin intake can be manipulated to test the accuracy or effectiveness of a new product under varying conditions or to compare it to existing products.According to the researchers, this technology is an improvement over other simulators, which provide only average or group-level results."This simulator allows 'in silico' pre-clinical experiments to be conducted at the level of an individual, revealing inter-personal differences due to treatment," said Kovatchev, director of the diabetes technology center at U.Va. and an internationally renowned diabetes technology scientist.Kovatchev and Breton are researchers in the U.Va. School of Medicine's Department of Psychiatry and Neurobehavioral Sciences. Kovatchev holds a joint appointment in the School of Engineering and Applied Science's Department of Systems and Information Engineering and was named U.Va. Patent Foundation's 2011 Edlich-Henderson Inventor of the Year for the development of novel computational methods that have advanced the state of diabetes research.Approximately 60 academic and industrial sites are already using a test version of the simulator for research purposes.Kurt Wassenaar, Epsilon CEO, said that computational modeling can help improve and accelerate new products for diabetes care. "We are very enthusiastic about the opportunity to build and provide a robust commercial version of the model technology to the diabetes research and disease management community," he said.The simulator project has been funded by the Juvenile Diabetes Research Foundation and the National Institute of Diabetes and Digestive and Kidney Diseases. A patent on the simulator is pending.
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