Study to Assess if Knowing About Genetic Risk For Kidney Disease Changes a Person's Lifestyle
Posted: November 11, 2014 at 5:43 pm
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Newswise (NEW YORK November 10) The Icahn School of Medicine at Mount Sinais Institute for Personalized Medicine is launching a study designed to learn whether patients, who are aware of their genetic predisposition to chronic kidney disease, are more inclined to engage in proactive lifestyle modification with their primary care physician.
Chronic kidney disease affects about 26 million American adults. Many studies have shown that African Americans are up to seven times more likely than any other population to develop high blood pressure and subsequent complications, such as kidney disease. A large fraction of the kidney disease disparity is attributable to variations, or differences, in a single gene called apolipoprotein L1 (APOL1). In Mount Sinais specialized laboratory, variations in the APOL1 gene can be identified with a simple blood test.
Erwin Bottinger, MD, Director, Charles Bronfman Institute for Personalized Medicine in the Icahn School of Medicine at Mount Sinai is one of the studys Principal Investigators. Many patients do not have their blood pressure adequately controlled to minimize the risk for complications such as kidney disease. We will test whether sharing genetic risk information with patients and alerting their doctors through a patient's electronic health record, will achieve better control of blood pressure to reduce kidney disease risk.
Dr. Bottinger and Co-Principal Investigator Carol Horowitz, MD, MPH, are seeking to enroll approximately two thousand African American participants with hypertension for their year-long study: Genetic testing to Understand and Address Renal Disease Disparities (The GUARDD Study). Funded by the National Human Genome Research Institute (NHGRI) the study will be conducted in a network of community health centers and primary care facilities in Northern Manhattan and the South Bronx, affiliated with the Icahn School of Medicines Institute for Family Health and at primary care facilities of The Mount Sinai Health System.
At the first study visit, all study participants will be asked to complete medical and family health histories, blood pressure, height, and weight measurements. If eligible, each individual will be randomly assigned to one of two groups. Group 1 will have blood drawn for genetic testing and return within 4 weeks later to discuss the results with a member of the research team. They will also be given printed information to share with their primary care physician. Those participants will return after 3 months and 12 months for a blood pressure check and to complete follow-up surveys.
Individuals in Group 2 will receive the genetic testing until the end of the study but will be asked to return at 3 and 12 months for the same measurements as those in Group 1. Primary care providers for patients enrolled in the study will also receive the results of the APOL1 genetic test and information about the test through alerts in the patients electronic medical record.
We are translating the latest scientific developments for both patients and their primary care physicians, says Dr. Horowitz. While we cant guarantee results, we are hopeful participants who know they carry the APOL1 gene variant will engage in proactive behaviors, under their doctors supervision to forestall renal failure often associated with hypertension.
Neil Calman, MD, President and Chief Executive Officer of the Institute for Family Health, and Professor and Chair of Family Medicine and Community Health at Mount Sinai said, Armed with this genetic information, African Americans with high blood pressure who carry variations in this gene will be able to focus on the management of their high blood pressure with their primary care providers, helping to prevent the onset of the devastating effects of kidney failure.
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Study to Assess if Knowing About Genetic Risk For Kidney Disease Changes a Person's Lifestyle