Saha SA and Tuttle KR. Influence of glycemic control on the development of diabetic cardiovascular and kidney disease. Cardiol Clin 28:497-516,2010.
Diabetes mellitus leads to the development of a host of micro- and macrovascular complications, which collectively lead to substantial morbidity and mortality. Among the microvascular complications of diabetes, diabetic kidney disease is the most common. Macrovascular complications from diabetes lead to a 2- to 4-fold increase in the incidence of cardiovascular disease and up to twice the mortality from cardiovascular causes as compared with nondiabetic individuals. This article discusses the various drug classes used to treat diabetes mellitus, and reviews the current clinical evidence linking glycemic control using these drug classes on diabetic kidney and cardiovascular disease.
Raabe RD, Burr RB, Short R. One-year cognitive outcomes associated with carotid artery stent placement. J Vasc Interv Radiol 21:983-988;2010.
Purpose
To assess relatively long-term (ie, 1 year) neurocognitive outcomes of patients undergoing carotid artery stent (CAS) placement with cerebral protection.
Materials and Methods
Sixty-two patients (19 symptomatic; mean age, 73 years) with significant carotid stenosis (≥ 70% for symptomatic patients, ≥ 80% for asymptomatic patients) underwent CAS placement with embolic protection. Cognitive function was assessed prospectively with use of a battery of standardized tests administered at baseline (1-5 days before CAS endovascular therapy) and at 3, 6, and 12 months after CAS placement. Diffusion-weighted imaging (DWI) was performed before the procedure and within 24 hours after CAS placement.
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Rodney D. Raabe, MD is the Principal Investigator for a new research trial being conducted at Providence Medical Research Center. This is a trial primarily sponsored by the National Heart, Lung and Blood Institute investigating the treatment of Deep Vein Thrombosis. The name of this trial is:Acute Venous Thrombosis: Thrombosis Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)
Deep vein thrombosis, or DVT, is a blood clot that forms in a vein deep in the body, usually in the leg. Blood clots occur when blood thickens and clumps together. Most deep vein blood clots occur in the lower leg or thigh. They also can occur in other parts of the body.
People who develop DVT often have one or more of the following risk factors:
1. Recent major trauma (e.g. car accident with bony fractures).
2. Recent major surgery.
3. Cancer.
4. Immobilization due to medical illness, paralysis, or other condition.
5. Pregnancy.
6. Hormonal treatments (e.g. birth control pills).
7. Disorders of the blood clotting system (often inherited).
Approximately 25 to 50% of individuals treated for a DVT have post-thrombotic syndrome (PTS) after treatment of the condition. This adds up to about 50,000 -100,000 patients a year who develop PTS. Post-thrombotic syndrome includes any number of on-going symptoms such as swelling of the affected limb, pain, heaviness and fatigue, purpura (bleeding into the skin), increased skin pigmentation, eczematoid (eczema-like) dermatitis, pruritus (itchiness), ulceration, and cellulitis (bacterial infection just below the skin). All of these complications result from the impaired return of blood through the veins of the lower leg to the heart.
The ATTRACT Study is being conducted to determine if an investigational method for delivering a clot busting medication can safely prevent PTS and improve quality of life in patients with a blood clot in the leg. Participants will be followed for 2 years. All participants will receive blood-thinning drugs: the standard treatment for blood clots. In addition, half of the study participants will be randomly chosen to have their clot dissolved using a clot-busting drug (TPA) that a study doctor will inject directly into the clotted vein through a specially designed investigational drug delivery catheter.
Participants are followed for 2 years to assess possible symptoms related to the clot and how well the standard and investigational treatments prevent the occurrence of Post-Thrombotic Syndrome.
For more information about this study use the "search box" and enter the word ATTRACT.
Podium Abstract Presentation for the American Society of Colon and Rectal Surgeons 2010.
S.Buntzen,P.Lehur, S. McNevin, A. Mellgren, S. Laurberg, R. Madoff.
Purpose: Restoration of adequate sphincter function in case of end-stage fecal incontinence (FI) is still a challenge. We report our initial clinical results following implantation of a novel magnetic anal sphincter (MAS).
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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)
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.
Providence Sacred Heart Medical Center and Providence Medial Research Center have been selected as one of about 50 sites for a National Institutes of Health study to determine if aggressive treatment of stroke victims for high blood pressure and cholesterol-along with placing a stent to widen a narrowed artery in a patient's brain-can reduce their risk of having a second stroke.
"People who suffer an ischemic stroke, the most common kind of stroke, have a 30 percent to 50 percent chance of having another stroke," says Dr. Chris Zylak, a neurointerventional radiologist and the lead researcher for the study here. Drs. Zylak and Madeleine Geraghty, director of Sacred Heart's Primary Stroke Center, will treat study patients.
The best treatment for prevention of another stroke or TIA (transitory ischemic attack or mini stroke) in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life.
The SAMMPRIS trial is a study funded by The National Institutes of Health (NIH). It is being done to determine whether intracranial stenting (a device inserted in a blood vessel in the brain) combined with intensive medical therapy is better than intensive medical therapy alone for preventing stroke or death in individuals who have had a stroke or TIA caused by a narrowing in one of the arteries in the brain.
New England Journal of Medicaine Volume 361:1339-1348, October 1, 2009
Mark B. Landon, M.D., Catherine Y. Spong, M.D., Elizabeth Thom, Ph.D., Marshall W. Carpenter, M.D., Susan M. Ramin, M.D., Brian Casey, M.D., Ronald J. Wapner, M.D., Michael W. Varner, M.D., Dwight J. Rouse, M.D., John M. Thorp, Jr., M.D., Anthony Sciscione, D.O., Patrick Catalano, M.D., Margaret Harper, M.D., George Saade, M.D., Kristine Y. Lain, M.D., Yoram Sorokin, M.D., Alan M. Peaceman, M.D., Jorge E. Tolosa, M.D., M.S.C.E., Garland B. Anderson, M.D.,
ABSTRACT
Background It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes.
Methods Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.
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Longitudinal Relationships among Coronary Artery Calcification, Serum Phosphorus, and Kidney Function
Clinical Journal of the American Society of Nephrology Published ahead of Print November 5, 2009
Katherine R. Tuttle and Robert A. Short
Background and objectives: Coronary artery calcification (CAC) is common in advanced chronic kidney disease (CKD), yet its onset and time course are uncertain. The study objective was to assess longitudinal relationships among CAC, kidney function, and traditional and putative cardiovascular disease (CVD) risk factors.
Advanced glycation end products (AGEs) are proinflammatory mediators implicated in the pathogenesis of diabetic kidney disease (DKD). In this study, dose-dependent effects of angiotensin receptor blockade on urinary AGEs were evaluated in patients with DKD. Patients with type 2 diabetes and proteinuria >=500 mg/d (n = 11) were compared with diabetic controls without DKD (n = 10) and normal controls (n = 11). After a 2-week washout period, DKD participants were treated with candesartan doses progressively increasing from 8, 16, 32, to 64 mg/d every 3 weeks for a total of 12 weeks. Other antihypertensive agents were adjusted to maintain stable blood pressure.
Radica Z. Alicic, MD, Sandeep A. Saha, MD, Robert A. Short, PhD, and Katherine R. Tuttle, MD
Current Hypertension Reports 2009, 11:354-362
Albuminuria has been recognized as a risk marker for both chronic kidney disease and cardiovascular disease in large observational cohorts. In addition, post hoc analyses of many large randomized trials have found a positive relationship between albuminuria and adverse renal and cardiovascular outcomes, leading some to suggest that albuminuria may be a potential therapeutic target for antihypertensive treatment. However, direct clinical evidence linking albuminuria reduction to reduction in adverse renal and cardiovascular events is scarce. (Abstract on line)
Comprehensive lifestyle change can impact health favorably in many domains, from prevention and treatment of various diseases to improved functional status and quality of life. Although habitual behaviors clearly influence chronic kidney disease (CKD), lifestyle change often is not stressed in the clinical setting. The purpose of this review is to provide a critical appraisal of the scientific basis for effects of lifestyle on CKD and practical strategies that promote healthy behaviors. This review begins with a clinical case presentation to provide context for the scientific discussion. Dietary composition of macronutrients, particularly protein intake, is highlighted. Clinical evidence is presented for avoiding protein excess, a contemporary problem in the typical overeating environment of the developed world.
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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.
Katherine R. Tuttle, MD; Joan E. Milton, MS, RD, CD Arch Intern Med. 2009;169(11):1027
Dr. M. Shane McNevin is the Principal Investigator for several research trials at Providence Sacred Heart Medical Center and Children's Hospital (SHMC). Dr. McNevin is a leading physician at the Providence Continence Center, as well as the program director for the gastrointestinal section of Providence Cancer Center. Board certified in general surgery, along with colon and rectal surgery, he is an expert in the diagnosis, medical management and surgical treatment of colorectal and anal tumors, inflammatory bowel disease and pelvic floor disorders. Dr. McNevin is also highly respected by his peers across the nation. In the last year alone, he has been invited to share his expertise at four major professional conferences.
Dr. Mc Nevin has been selected as an investigator for new treatments for fecal incontinence (FI). These research trials examine the effectiveness and safety of new treatment methods and are being run in only a handful of locations in the United States. Dr. Mc Nevin was chosen as an investigator by the companies sponsoring these trials because he is a leader in the field of colon and rectal surgery. In addition to his work on these ground breaking trials, Dr. McNevin also conducts his own original research through his office at Surgical Specialists of Spokane.
SHMC is currently participating in a research trial for the treatment of FI. This study, sponsored by Torax Medical, Inc., is investigating the safety and effectiveness of a revolutionary new device to treat FI. This is a study being done in only four locations across the United States. Current treatment options for FI are limited. These include standard treatment with sphincteroplasty (surgical repair of the rectal sphincter), bulking agents (adding fiber to the diet), or Radio Frequency delivery to the anal canal which can cause tissue shrinkage and tightening of muscle tissue.
This current study will evaluate a novel device called the Magnetic Anal Sphincter (MAS).The MAS is an implantable device made up of a series of magnetic beads. The beads are attached with little wires to create a "necklace" shape. The device is implanted around the muscles that control continence. The attractive force of the magnetic beads provides additional strength to these muscles.
It's a simple premise, but it's the foundation of the "Start!" movement, from the American Heart Association (AHA). Research has shown that you can gain about two hours of life for every hour of regular vigorous exercise you do. You couldn't find a better two-for-one deal if you tried!
It's a good thing, too. The American workforce is becoming more and more sedentary. As a result, our waistbands are growing. So are our healthcare costs and the number of preventable illnesses.
Start! is here to stop the trend. Walking is simply the first step toward a healthier lifestyle.
So join the Start! Movement. Check out the AHA free tools on-line to motivate more Americans to Start! walking:
The Start! movement is here to motivate and encourage all Americans to take up walking and other healthy habits as part of their daily routine all year round, and to live longer, stronger, heart-healthy lives.
April 8th is National Start! Walking Day, we challenge you to join the nationwide campaign to get Americans walking! The goal of The American Heart Association is to walk a million steps and raise $1 million.
The AHA Challenge for You!
-
Start! by getting out and taking a WALK
- Then take 30 minutes to inspire your friends and family by sending them an email.
- Encorage them to take a WALK and join you in raising funds to fight our nation's No. 1 and No. 3 killers -heart disease and stroke.
There are 26 million American adults with Chronic Kidney Disease (CKD). Often there are no symptoms with early kidney disease so most people aren't even aware that they have CKD. Millions of others are not aware that they are at risk. High risk groups include those with diabetes, hypertension and family history of kidney disease.
African Americans, Hispanics, Pacific Islanders, Native Americans and Seniors are also at increased risk. The key to preventing the progression of kidney disease is early detection.
The National Kidney Foundation's Kidney Early Evaluation Program (KEEP®) offers free screening for those with certain risk factors including anyone 18 years and older with high blood pressure, diabetes or a family history of kidney disease. KEEP is designed to raise awareness about kidney disease among high risk individuals and provide free testing and educational information so that kidney disease and its complications can be prevented or delayed.
There are three simple tests that can be done to detect CKD. These tests are: blood pressure check, a urine test for urine albumin (protein in the urine) and a blood test for serum creatinine (a blood protein byproduct).
To help raise awareness, and appreciation for all the vital functions the kidneys perform, the National Kidney Foundation is encouraging Americans to learn more and take steps now to preserve kidney health. March 12 is World Kidney Day, the perfect time to get to know your kidneys and find out if you're at risk.
To find out more Click Here
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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CASE PRESENTATION
A 22-year-old African-American woman who has been dialysis dependent for four months due to hypertensive kidney disease is referred for kidney transplantation evaluation. Due to the recent occlusion of her left forearm arteriovenous graft, she is currently being dialyzed via a right internal jugular tunneled catheter. Her medications include methyldopa 250 mg bid, Tums 1000 mg with each meal and erythropoietin with dialysis. The patient is single without children, unemployed and lives with her 38 year old mother. She does not smoke or drink. Her review of systems is unremarkable. On physical exam, her weight is 284 pounds, height is 5 feet 2 inches and her body mass index is 51.9 kg/m2. The blood pressure is 130/80 and the cardiac and pulmonary exams are unremarkable. The surgeon feels she is otherwise a good candidate for transplantation except she must lose weight before being listed. What advice should she be given regarding weight loss?
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Katherine R. Tuttle , Am J Kidney Dis, 2009 Jan; 53(1): 12-15. (Commentary on the ACCORD Study Group: Effects of intensive Glucose lowering in type 2 diabetes. N Engl J Med 358: 2545-2559, 2008 and the ADVANCE Collaborative Group: Intensive blood glucose control and vascular outcomes in patients with type 2 daibetes. N Engl J Med 358: 2560-2572, 2008 )
The effects of intensive glycemic control on cardiovascular disease (CVD) outcomes in "high risk" type 2 diabetes are the subject of much debate. The New England Journal of Medicine recently published results of two landmark clinical trials in patients with type 2 diabetes and CVD or multiple risk factors, ACCORD (Action to Control Cardiovascular Risk in Diabetes, n=10,521) and ADVANCE (Action in Diabetes and Cardiovascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, n=11,140).1,2
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