Dr. Katherine Tuttle, Medical and Scientific Director at Providence Medical Research Center, was Co-Chair of the Work Group which developed new clinical practice guidelines for Diabetes and Chronic Kidney Disease. The Work Group included members from North America, Europe, and South America. As such, these guidelines for patient care will be widely adapted in the United States and throughout the world. The February supplement issue of The American Journal of Kidney Diseases (KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease.
Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154) presents a complete version of the guidelines, which are a culmination of over 3 years of rigorous evidence review and synthesis.
The guidelines provide recommendations for diagnosis and staging of diabetic kidney disease. Medical management of diabetes and chronic kidney disease is clearly defined and the best treatment approaches are described based on current evidence. The guidelines also emphasize the importance of diabetes prevention to reduce the burden of diabetic kidney disease. Special populations with increased susceptibility and risks are also addressed. The Work Group defined key research areas where evidence is lacking.
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Providence Medical Research Center is participating in a research project funded by the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health. The Insulin Resistance Intervention after Stroke (IRIS) trial proposes an innovative therapy based on 20 years of accumulating evidence linking insulin resistance to increased risk for stroke and other blood vessel diseases.
Each year in the United States 700,000 persons suffer an ischemic stroke. An ischemic stroke is caused by a reduction in blood flow to the brain. This can be caused by a blockage or narrowing in a blood vessel that supplies blood to the brain or when the blood flow is reduced because of a heart or other condition. Of the 500,000 Americans who suffer this type of stroke, 100,000 will die. Among the 400,000 who survive an ischemic stroke each year, many will have another stroke or heart attack within five years.
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Providence Medical Research Center is one of approximately 15 research centers nationwide asked to participate in a new research project called CLEVER. This study, sponsored by National Institutes of Health, is for individuals who have blockages in their iliac artery(ies) from a medical condition called peripheral arterial disease.
The iliac arteries are in the lower abdomen leading to the legs. Blockages here cause symptoms like pain or cramping in leg or hip muscles when walking, called "claudication." Several treatment options are available, including:
- Vascular surgery (replacing a portion of your leg artery)
- Stent placement (a metal mesh tube placed through a small tube (catheter) temporarily put into your leg artery)
- Exercise therapy
- Medications
All the above procedures and treatments are accepted standard treatments. Each has been shown to be effective for improvement of claudication symptoms. The purpose of the CLEVER study is to compare treatment options, side-by-side, to learn which is the most effective and safe treatment for patients with claudication.
Prevention of Diabetic Kidney Disease: Negative Clinical Trials With Renin-Angiotensin System Inhibitors , Robert G. Nelson, Katherine R. Tuttle. American Journal of Kidney Diseases March 2010 (Vol. 55, Issue 3, Pages 426-430)
The onset of diabetic kidney disease typically is marked by the development of increased urinary albumin excretion. Microalbuminuria, the earliest detectable increase in urinary albumin levels, is defined as an albumin-creatinine ratio in the range of 30-300 mg/g.1 Although there presently is a debate about whether albuminuria is an adequate biomarker of diabetic kidney disease, it remains the test most commonly used by clinicians and researchers alike to screen for diabetic kidney disease. Because angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are proven therapies for diabetic kidney disease characterized by macroalbuminuria (albumin-creatinine ratio > 300 mg/g), by logical extension, these agents might also prevent the development of microalbuminuria. The DIRECT (Diabetic Retinopathy Candesartan Trials)-Renal Program, published in 2009 in the Annals of Internal Medicine,2 and RASS (Renin-Angiotensin System Study), published in 2009 in the New England Journal of Medicine,3 test this hypothesis. (full article on line)
Tuttle KR. Protein kinase C-beta inhibition for diabetic kidney disease. Diabetic Res & Clin Practice 13:S70-S74,2008.
Amid the rapidly rising number of people with diabetes worldwide, the prevalence of diabetic kidney disease (DKD) is expected to increase considerably despite available treatments. Consequently, novel therapeutic agents are urgently needed. Ruboxistaurin mesylate is a bisindolylmaleimide that specifically inhibits the β isoform of protein kinase C (PKC). In experimental models of DKD, ruboxistaurin normalized glomerular hyperfiltration, decreased urinary albumin excretion, preserved kidney function, and reduced mesangial expansion, glomerulosclerosis, and tubulointerstitial fibrosis. These beneficial effects of ruboxistaurin, both alone and combined with renin-angiotensin system inhibition, have been observed in a variety of experimental models of DKD. A phase 2 study of PKC-β inhibition in persons with type 2 diabetes and DKD already treated with angiotensin converting enzyme inhibition and/or angiotensin receptor blockade has been conducted. Addition of ruboxistaurin for 1 year reduced urinary albumin, prevented an increase in urinary transforming growth factor-β, and stabilized estimated glomerular filtration rate. Based on secondary analyses of clinical trials in patients with diabetic retinopathy or neuropathy, ruboxistaurin appears safe and may also prevent onset of DKD. PKC-β inhibition holds promise as a new strategy to improve kidney disease outcomes in diabetes. Large-scale clinical trials will be required to confirm safety and to validate prospective benefits of ruboxistaurin on relevant clinical endpoints in DKD.
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Andrew S. Levey, MD, Daniel Cattran, MD, Aaron Friedman, MD, W. Greg Miller, PhD, John Sedor, MD, Katherine Tuttle, MD, Bertram Kasiske, MD, Thomas Hostetter, MD
American Journal of Kidney Diseases Volume 54, Issue 2, Pages 205-226
Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States.
The American Diabetes Association (ADA) reports there are currently 20.8 million people with diabetes mellitus (DM) in the United States, or 7-8% of the population, and approximately 1.5 million new cases are diagnosed each year. Approximately 44% of people who are newly diagnosed as having chronic kidney disease are individuals with DM.
Providence Medical Research Center (PMRC) is one of approximately 50-80 centers in North America who will be participating in a research study of an investigational drug for patients with Type 2 Diabetes Mellitus (T2DM). Management with current medications that treat the complications of T2DM, such as diabetic kidney disease, may not sufficiently reduce the rate and onset of damage to the kidneys. The consequence of this damage is improper filtering by the kidneys and excess protein in the urine or "proteinuria". Previous research has shown that treatments that reduce proteinuria, which is a common sign of T2DM related to declining kidney function, can slow progression of diabetic kidney disease. This study is designed to determine the effect of the investigational drug on proteinuria and also on kidney function.
There are many factors known to lead to the decline in renal function for people who have T2DM. High blood pressure, high blood sugar levels, and potentially high cholesterol levels all play a role in the loss of kidney function. Recent research has found another contributor to a decline in renal function is an increase in Connective Tissue Growth Factor (CTGF), a protein the body normally produces. CTGF acts along with many other proteins to regulate the production of fibrous tissues in the body. It is thought that when CTGF is too high, growth of this fibrous or scar-like tissue occurs in the kidney. This results in loss of kidney function and proteinuria. Previous studies have found that current medications that treat hypertension and diabetes may help to protect the kidneys from damage, but they do not completely normalize CTGF levels. This study will also examine the effects of an investigational drug on CTGF levels. We at Providence Medical Research Center are proud to be a part of this important study.
The Center for Maternal Fetal Medicine at Providence Sacred Heart Medical Center and Children's Hospital provides a wide spectrum of highly specialized diagnostic and therapeutic procedures to monitor pregnancy from conception through delivery. As part of their efforts to stay on the cutting edge of practice, our physicians participate in research trials.
Sacred Heart Perinatologists Dr. Reinaldo Acosta and Dr. Jorge Tolosa have been chosen as investigators in perinatal research by the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network.
The NICHD is one of the Institutes within the National Institutes of Health (NIH). In 1986, the NICHD created the MFMU Network to focus on clinical questions in maternal fetal medicine, particularly with respect to the continuing problems of preterm birth, low birth weight, and medical problems of pregnancy. Operating under cooperative agreements, the current Network is comprised of fourteen university-based clinical centers and a data coordinating center. Since its creation, the MFMU Network has been a driving influence for introducing new scientific discoveries into the field of perinatology. More than 30 randomized clinical trials, cohort studies and registries have been completed or are in progress. The studies to date have not only identified new therapies and evaluated technologies used in maternal-fetal medicine, but also have helped to abolish practices that are not useful.
Click here to visit the Center for Maternal Fetal Medicine Web page.
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