Cholesterol, Blood Pressure Control May Reverse Atherosclerosis in Adults With Diabetes
April 08, 2008
April 8, 2008 (EurekAlert) - Aggressively lowering cholesterol and blood pressure levels below current targets in adults with type 2 diabetes may help to prevent – and possibly reverse – hardening of the arteries, according to new research supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. Hardening of the arteries, also known as atherosclerosis, is the number one cause of heart disease and can lead to heart attack, stroke, and death.
The three-year study of 499 participants is the first to compare two treatment targets for LDL (“bad”) cholesterol and systolic blood pressure levels, key risk factors for heart disease, in people with diabetes. Results are published in the April 9 issue of the Journal of the American Medical Association.
“This study provides good news for adults with type 2 diabetes,” said Elizabeth G. Nabel, M.D., NHLBI director. “These patients are two to four times more likely than people without diabetes to die from heart disease. For the first time, we have evidence that aggressively lowering LDL cholesterol and blood pressure can actually reverse damage to the arteries in middle-aged adults with diabetes.”
In the Stop Atherosclerosis in Native Diabetics Study (SANDS), approximately one-half of the participants (247) were asked to lower to standard levels their LDL cholesterol (to 100 milligrams per deciliter) and blood pressure (systolic blood pressure of 130 mmHg or lower), while the other half (252) aimed for more aggressive lowering of LDL cholesterol to 70 mg/dL or lower and of systolic blood pressure to 115 mmHg or lower. All participants were American Indians 40 years or older (average age of 56) who had diabetes, high blood cholesterol, and high blood pressure but no history of heart attack or other evidence of heart disease. The study was conducted at four clinical centers in southwestern Oklahoma; Phoenix, Ariz.; northeastern Arizona; and South Dakota. All participants continued to receive their medical care, including diabetes management, dietary and exercise counseling, and smoking cessation, from their health care providers with the Indian Health Service. Like the NIH, the Indian Health Service is part of the U.S. Department of Health and Human Services.
“American Indians have a high rate of diabetes and cardiovascular disease related to diabetes, but there are few clinical trials that address these issues in this population,” said Barbara V. Howard, Ph.D., of MedStar Research Institute in Hyattsville, Md., lead author of the paper. “These study results provide needed evidence to help develop community-based programs to treat and prevent the epidemic of cardiovascular disease among American Indians. At the same time, we are increasing our understanding of the effects of intensively lowering cholesterol and blood pressure in adults with type 2 diabetes, which might also apply to other populations.”
During the three-year study, participants were examined by study clinicians one month after enrollment, then every three months, to assess their blood cholesterol and blood pressure levels and general well being. Food and Drug Administration-approved blood pressure and cholesterol medications were added and adjusted as needed to help participants achieve their treatment goals. The same medications were available to participants in the standard and the aggressive treatment groups. Participants were also encouraged to follow lifestyle approaches to help meet their blood pressure and cholesterol treatment targets, such as following a heart-healthy eating plan, being physically active, maintaining a healthy weight, and not smoking.
To assess the impact of the treatments on the participants’ cardiovascular health, researchers used ultrasound to measure the thickness of the carotid (neck) artery -- an indication of hardening of the arteries, a leading effect of high blood pressure and cholesterol and an early sign of cardiovascular disease. In addition, ultrasound was also used to measure the size and function of the left ventricle, the heart's main pumping chamber. Enlarged hearts are known to be predictors of increased risk of heart attack and stroke. These measurements were taken at enrollment, at 18 months, and at 36 months, when the study ended.
On average, participants in both groups reached and maintained their target goals for blood cholesterol and blood pressure levels. The numbers of heart attacks and other cardiovascular events were similar between the two groups and lower than expected.
In addition, carotid artery thickness measurements of participants in the aggressive treatment group were significantly lower than those in the standard treatment group. Researchers report that, compared to baseline, carotid artery thickness increased slightly in the standard group and regressed in the aggressive treatment group, indicating a partial reversal of atherosclerosis. Furthermore, although heart size decreased from baseline in both groups, the beneficial change was significantly greater among participants in the aggressive treatment group.
“Many patients with diabetes do not reach their blood pressure and cholesterol goal levels and thus remain at high risk for heart attacks and stroke,” noted Howard. “In our study, participants successfully managed their blood cholesterol and blood pressure to reach their goal levels. Our message to doctors, nurses, and patients is that you can reach your goal levels, and we should work together to help you do that.”
As with any therapy, the benefits and risks must be considered for each patient. In SANDS, participants in the aggressive treatment group on average needed more medications and higher doses than the standard treatment group, and they were slightly more likely to have side effects from blood pressure-lowering medications than those in the standard group. Such adverse effects generally resolved, however, after the medication was changed or the dose reduced. There were no differences in side effects related to cholesterol-lowering drugs between the standard and the aggressive treatment groups.
“These encouraging findings from SANDS suggest that more aggressive blood pressure and cholesterol targets than those currently recommended in patients with diabetes may reduce their future cardiovascular risk,” said Jerome L. Fleg, M.D., NHLBI project officer of the study and a coauthor of the paper. “Longer term followup of this population as well as additional studies in other populations are needed to confirm the benefit and cost-effectiveness of these lower targets.”
Posted by dlife at 02:54 PM | Comments (0)
Red Wine, Tea, May Help Regulate Blood Sugar in Type 2 Diabetics
April 02, 2008
April 2, 2008 (Newswise) — Red wine has been shown to protect people from heart disease, even when they follow a diet high in saturated fat, and the healing powers of tea are becoming the stuff of legend. Now, researchers at the University of Massachusetts Amherst have shown that these beverages may hold promise for regulating the blood sugar of people with type 2 diabetes.
Results have been published in the Journal of Food Biochemistry. Researchers include food scientists Kalidas Shetty, Young-In Kwon and Emmanouil Apostolidis.
“Levels of blood sugar, or blood glucose, rise sharply in patients with type 2 diabetes immediately following a meal,” says Shetty. “Red wine and tea contain natural antioxidants that may slow the passage of glucose through the small intestine and eventually into the bloodstream and prevent this spike, which is an important step in managing this disease.”
One of the main challenges in managing diabetes is keeping blood sugar levels as normal as possible with few major fluctuations, which can prevent the disease from contributing to heart disease and high blood pressure as well as damaging the eyes, kidneys, nerves and blood vessels.
Both red and white wines were tested in the laboratory using in vitro enzyme studies to determine how well they could inhibit the activity of a target enzyme called alpha-glucosidase, responsible for triggering the absorption of glucose by the small intestine. Red wine was the winner, able to inhibit the enzyme by nearly 100 percent. Values for white wine hovered around 20 percent.
This was clearly related to the amount of a specific type of antioxidants, called polyphenolics, found in the wines. “Our testing showed that red wine contains roughly ten times more polyphenolics than white wine,” says Shetty. “Laboratory results suggest that these compounds, found in many plant-based foods, may play a role in inhibiting alpha-glucosidase and slowing the passage of carbohydrates into the bloodstream.”
Alpha-glucosidase is the target for current drugs used to treat type 2 diabetes and the development of new drugs.
The team also tested four kinds of tea, including black, oolong, white and green teas. Water extracts of black tea had the highest effect on inhibiting the activity of
alpha-glucosidase, followed by white tea and oolong tea.
Wine and tea had no effect on a pancreatic enzyme called alpha-amylase that breaks down starch, which could help patients avoid the side effects of medications used to control blood sugar.
“A major drawback of medications that control both enzymes is the bacterial fermentation of undigested carbohydrates, especially starch, in the colon, which can lead to side effects such as flatulence, bloating and diarrhea,” says Shetty. “Tea and wine had no effect on the breakdown of starch by alpha-amylase, which could potentially help patients avoid these side effects.”
Another benefit is that the polyphenolics in wine and tea could also help in protecting the rest of the body from the additional complications of diabetes such as high blood pressure and heart disease. Diabetes places a stress on the entire body by increasing the production of free radicals, including molecules that react with oxygen, which degrade cellular function. Both red wine and tea contain antioxidants with proven health benefits, and have the potential to manage heart disease, high blood pressure and perhaps contribute to the prevention of cancer, which are all linked to free radicals.
“These results provide strong evidence for further studying the use of wine and tea to manage some stages of type 2 diabetes using animal models and clinical studies, and point to the importance of an antioxidant-rich diet as part of an overall management strategy,” says Shetty. “This concept is not new, but we are finding clear cellular targets for the functions of dietary polyphenolics. Using specific beverage combinations could generate a whole food profile that has the potential to manage type 2 diabetes and its complications, especially in the early stages.”
Posted by dlife at 02:24 PM | Comments (22)
Extra vitamin D in Early Childhood Cuts Adult Diabetes Risk
March 13, 2008
Vitamin D supplementation in early childhood and risk of type 1 diabetes: a systematic review and meta-analysis
March 13, 2008 (EurekAlert) - Vitamin D supplements in early childhood may ward off the development of type 1 diabetes in later life, reveals a research review published ahead of print in the Archives of Disease in Childhood.
Type 1 diabetes is an autoimmune disorder, in which insulin producing beta cells in the pancreas are destroyed by the body’s own immune system, starting in early infancy. The disease is most common among people of European descent, with around 2 million Europeans and North Americans affected.
Its incidence is rising at roughly 3% a year, and it is estimated that new cases will have risen 40% between 2000 and 2010.
A trawl of published evidence on vitamin D supplementation in children produced five suitable studies, the pooled data from which were re-analysed.
The results showed that children given additional vitamin D were around 30% less likely to develop type 1 diabetes compared with those not given the supplement.
And the higher and the more regular the dose, the lower was the likelihood of developing the disease, the evidence suggested.
Levels of vitamin D, and sunlight, from which the body manufactures the vitamin, have been implicated in the risks of developing various autoimmune disorders, including multiple sclerosis and rheumatoid arthritis.
And there is a striking difference in the incidence of type 1 diabetes according to latitude and levels of sunlight exposure, with a child in Finland 400 times more likely to develop the disease than a child in Venezuela, say the authors.
Further evidence of vitamin D’s role comes from the fact that pancreatic beta cells and immune cells carry receptors or docking bays for the active forms of the vitamin.
Posted by dlife at 10:16 AM | Comments (1)
Gene Chip Technology Unlocks Window on Diabetes
April 27, 2006
April 27, 2006 (Newswise) — Groundbreaking research using new Gene Chip technology has discovered a gene that appears to be linked to diabetes. The research was presented Thursday at the 15th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists.
The research was presented by C. Ronald Kahn, M.D., President and Director of the Joslin Diabetes Center and Professor of Medicine at Harvard Medical School. Dr. Kahn’s research is part of the Diabetes Genome Anatomy Project (DGAP), and shows that a newly discovered gene called ARNT (Aryl hydrocarbon Receptor Nuclear Translocator) may be closely linked to diabetes. In laboratory studies, mice without the ARNT gene were compared to normal mice. The mice without the ARNT gene developed hyperglycemia and diabetic symptoms.
Dr. Kahn says that this research is “opening up new diagnostic avenues for diabetes”.
“This breathtaking basic science should permit us a better understanding of the development of diabetes, and hopefully allow new therapeutic tools to manage diabetes more effectively,” said Victor L. Roberts, MD, Clinical Professor of Medicine at the University of Florida and member of the National Board of Directors of AACE.
The link between ARNT and its activity is being closely studied for its role in developing type 2 diabetes in humans. The gene chip technology is critical for the continued advances in this research. Gene chip technology uses a half inch chip in a handheld device that probes and displays RNA matches. RNA is critical for gene expression in health and disease. This area of investigation is known as genomics.
The Diabetes Genome Anatomy Project (DGAP) represents a unique, multidimensional initiative whose goal is to unravel the interface between insulin action, insulin resistance and the genetics of type 2 diabetes.
Diabetes is just one of the many endocrine disorders that is being addressed during the 15th Annual AACE Clinical Congress. New research involving vitamin D, thyroid cancer, androgen use, and performance enhancing drugs will be presented. In addition, hundreds of medical abstracts ranging from osteoporosis to reproductive endocrinology will be presented at exclusive poster sessions for registered media.
Posted by dlife at 09:52 AM | Comments (0)
Medtronic Receives FDA Approval for World's First Insulin Pump with Real-Time Continuous Glucose Monitoring
April 13, 2006
MiniMed Paradigm® REAL-Time System Allows Patients to Make Immediate Diabetes Management Decisions; Marks Major Step Toward an Artificial Pancreas
MINNEAPOLIS, April 13, 2006 — Medtronic, Inc. (NYSE: MDT) today announced FDA approval of the MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System, a progressive new therapy available for patients who use insulin to treat diabetes. For the first time in the history of diabetes management, an insulin pump integrates with REAL-Time continuous glucose monitoring (CGM). This new technology will help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence, and heart disease.
The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring (CGM) System, and a MiniMed Paradigm insulin pump. The REAL-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day – nearly 100 times more information than three daily fingersticks. REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick. The REAL-Time CGM System component is indicated for any patient 18 years of age or older, and insulin pump therapy for all patients requiring insulin.
“The approval of the MiniMed Paradigm REAL-Time System opens the door to the next generation of diabetes management,” said Robert Guezuraga, president, Medtronic Diabetes. “As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives.”
Integrating an insulin pump with REAL-Time CGM is a major step toward the development of a “closed-loop” insulin delivery system that may one day mimic some functions of the human pancreas. Medtronic is testing future systems that would employ advanced scientific algorithms to proactively recommend insulin dosages to patients. Through this process, Medtronic anticipates developing an external, closed-loop system designed to simplify and improve patient diabetes management.
The MiniMed Paradigm REAL-Time System’s continuous glucose sensor is a tiny electrode that is inserted under the skin using the Sen-Serter®, a small device that patients or their caregivers can use at home to make sensor insertion easier. The sensor measures glucose in the interstitial fluid found between the body’s cells, and is typically discarded and replaced after three days of use. Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the insulin pump, which displays the glucose value, three-hour and 24-hour trend graphs, as well as arrows to indicate how quickly glucose is moving up or down. In addition, an alarm alerts patients when glucose levels become too high or too low.
The MiniMed Paradigm REAL-Time System includes a “smart” MiniMed Paradigm insulin pump, which has a powerful built-in Bolus Wizard® calculator to manage the complex diabetes math for patients. Smart insulin pumps recommend insulin dosages after considering the amount of insulin still “active” in the body, helping patients avoid dangerous hypoglycemic episodes caused when too much insulin is delivered.
Current standards for assessing glucose control include A1C tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control over a three-month period, is important for long-term management, but it is only an average and does not reveal day-to-day glucose fluctuations that can damage the body. In turn, fingerstick measurements only reveal a glucose value at a single moment in time. As a result, patients are unable to detect approximately 60 percent of low glucose (hypoglycemia) events, and have difficulty assessing glucose fluctuations while they sleep. In contrast, REAL-Time CGM allows patients to view glucose trends throughout the day and night, and understand how fast, and in what direction, their glucose levels are heading. By discovering how diet, exercise, medication and lifestyle affect their glucose levels, patients can make more informed self-management decisions and achieve a greater sense of confidence when managing their disease.
About Insulin Pump Therapy
An insulin pump is a small pager-size device that delivers insulin around the clock, much like a healthy pancreas. It is the most advanced method for precise and adjustable insulin delivery. Unlike injection therapy, insulin pump users can program their insulin pump to deliver insulin at varying rates to meet their changing insulin needs throughout the day and night. In addition, insulin can be delivered on demand at the touch of a few buttons. Many patients experience improved quality of life with insulin pump therapy, ridding themselves of multiple injections, strict meal schedules and rigid sleep patterns that are associated with injection therapy.
Diabetes Statistics
According to the American Diabetes Association, almost 21 million Americans (seven percent of the population) have the disease. Diabetes affects children and adults, costing the United States more than $132 billion in direct and indirect costs.
About Medtronic Diabetes
Medtronic Diabetes (www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring. The company’s products include external insulin pumps, continuous glucose monitoring systems and related disposable products.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.
Posted by dlife at 10:12 AM | Comments (0)
DexCom Receives FDA Approval for STS(TM) Continuous Glucose Monitoring System
March 27, 2006
SAN DIEGO, March 27, 2006, (BUSINESS WIRE) -DexCom, Inc. (NASDAQ:DXCM) today announced that it has received Food and Drug Administration (FDA) approval for its STS(TM) Continuous Glucose Monitoring System, a first generation device designed to help people with diabetes more conveniently and effectively manage their blood sugar levels. Widely recognized as one of the leading causes of death and disability in the United States, diabetes is a chronic disease with no known cure that afflicts approximately 20 million people in the U.S., according to the Center for Disease Control (CDC). In the U.S., diabetes is the leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.
"We are very pleased the FDA has approved the DexCom STS Continuous Glucose Monitoring Product and are hopeful this novel technology will improve the quality of life for people living with diabetes," said Andrew P. Rasdal, DexCom President and Chief Executive Officer.
The DexCom STS consists of a tiny wire-like sensor that is inserted by the patient just under the skin. The sensor continuously measures glucose levels which are transmitted wirelessly to the cell phone-like STS Receiver. With the push of a button, the handheld Receiver conveniently provides the patient with real-time glucose measurements and trends, as well as providing alerts to warn of high and low glucose levels. The results of a study on the DexCom STS published in the January 2006 edition of Diabetes Care, a publication of the American Diabetes Association, demonstrated patients could achieve better control of glucose levels when using the information from the DexCom STS.
"We are appreciative of the efforts by the FDA and FCC to help make this technology available to people with diabetes," said Rasdal. "Further, we are especially thankful for the support of the patients, physicians, nurses, and diabetes educators who have participated in our clinical studies supporting this approval."
DexCom management will hold a conference call starting at 4:30 PM (Eastern Time) on Monday, March 27, 2006 to discuss this important development. The conference call will be concurrently webcast. The link to the webcast will be available on the DexCom Inc. website www.dexcom.com under the investor webcast section and will be archived for future reference. To listen to the conference call, please dial (800) 811-0667 (U.S./Canada) or (913) 981-4901 (International) and use the participant code "6796471" approximately five minutes prior to the start time.
We have not sold any of our products to date. Successful commercialization of our products is subject to various risks and uncertainties, including possible delays in our development program, the inability of patients to receive reimbursements from third-party payers, a lack of acceptance in the marketplace by physicians and patients, inadequate financial and other resources, and the inability to manufacture products in commercial quantities at an acceptable cost.
Posted by dlife at 10:42 AM | Comments (0)
Abbott Receives FDA Clearance to Market New Blood Glucose Monitor
March 23, 2006
New Glucose Meter Requires Tiny Blood Sample, Provides Results in Just Five Seconds
ALAMEDA, Calif., March 13 (PRNewswire-FirstCall) - Abbott Diabetes Care announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FreeStyle(R) Freedom(TM) blood glucose monitoring system for consumer use.
FreeStyle Freedom offers virtually pain-free testing because it measures glucose levels using a very small blood sample size (0.3 micro liter), the smallest sample size required of any blood glucose monitoring product on the market. FreeStyle Freedom provides results in just five seconds and features a large, high contrast display, making it easy to read, and easy to hold. The new meter also allows people with diabetes to test on less sensitive parts of the body such as the forearm, thigh and palm. FreeStyle blood glucose meters offer the most approved alternative testing sites of any glucose monitoring system available.
"To successfully manage diabetes, patients must monitor their blood glucose levels frequently," said Sherwyn L. Schwartz, M.D., founder and chief executive officer of the Diabetes & Glandular Disease Clinic in San Antonio, TX. "In clinical trials, we found FreeStyle Freedom to be very accurate, and the small sample size and rapid test time associated with this new blood glucose meter may make testing less painful and could ultimately encourage those with diabetes to test more often," Dr. Schwartz added.
FreeStyle Freedom uses a technology exclusive to all FreeStyle meters based on coulometric measurement. This unique, patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Coulometric technology has already been used by people with diabetes worldwide in more than 2 billion blood glucose tests using FreeStyle blood glucose strips.
"FreeStyle Freedom expands Abbott's product line of innovative, easy-to- use and less painful blood glucose testing devices to meet the diverse needs of people with diabetes," said Ed Fiorentino, president of Abbott Diabetes
Care.
FreeStyle Freedom blood glucose monitoring systems will be available in April, 2006.
Posted by dlife at 11:04 AM | Comments (0)