Category: Diabetes 101

Patients suffering with Type 2 diabetes are commonly prescribed a combination of medications designed to lower LDL cholesterol, or bad cholesterol, and their triglyceride levels while simultaneously raising HDL cholesterol, or good cholesterol. It has been accepted by the medical community for quite a while that this combination of medication mitigates the effects of diabetes by lowering the risk of heart attacks.

However, that knowledge has been challenged recently in the New England Journal of Medicine. The combination of medication was recently evaluated for effectiveness by a Food and Drug Administration panel and three physicians who served on the panel say that these drugs have not demonstrated any effectiveness in lowering the risk of heart attacks in Type 2 diabetics who have higher levels of cholesterol.

The drugs are called fibrates and doctors prescribe them to raise HDL cholesterol levels while lowering blood triglyceride levels.

Fibrates are commonly prescribed to diabetics as companion medications to statins — drugs that lower levels of LDL cholesterol. There are three fibrates approved for use in the United States by the FDA, including gemfibrozil (Lopid), fenofibrate (Tricor) and fenofibric acid (Trillipix). The sales of these three drugs run into the billions of dollars, reflecting their popularity with physicians prescribing them for patients with diabetes or obesity.

“There have been few studies regarding the clinical outcome efficacy of fibrates,” said Sanjay Kaul, MD. Kaul is one of the doctors challenging the hypothesis that fibrates reduce risk of heart attacks and is director of the Cardiology Fellowship Training Program at Cedars-Sinai Heart Institute. According to Kaul, “Thousands and thousands of Americans take fibrates every day but so far, there are no long-term studies showing that fibrates lower cardiovascular risk or improve survival among diabetes patients who are also on statins.”

The doctors have suggested that more studies be performed to determine the efficacy of fibrates. However, they did recommend that doctors continue to prescribe the fibrate-statin combination of medication to diabetics who are at elevated risk for heart attacks, but only after the patients have been treated with statins to establish control of LDL cholesterol levels.

High blood triglyceride levels have been demonstrated to be a risk factor for heart disease and stroke as well as atherosclerosis, or hardening of the arteries. Triglyceride levels are increased by diets heavy in carbohydrates, such as those where carbohydrates make up 60 percent or more of caloric intake, especially in patients who already exhibit insulin resistance. Patients with high triglyceride levels can reduce those levels with exercise and by consuming omega-3 fatty acids from sources such as fish and flax seed oil. While United States residents are recommended to eat 3 grams of omega-3 fatty acids every day, most people do not consume that amount. Consumption of omega-3 fatty acids should also be balanced with consumption of omega-6 acids.

Clinical trials have shown that although treatment with fibrates alone does reduce the risk of non-fatal heart attacks, it does not reduce the risk of mortality. Fibrates have been used since the 1930s but their mechanism of reducing LDL cholesterol was not fully understood until the 1990s, when it was shown that they activate a type of cellular receptor called PPARs that regulate carbohydrate and fat metabolism. When activated, PPARs actually alter cellular DNA to increase fat metabolism, or the body’s use of stores of body fat to provide energy.

Fat Levels Higher in Thin Children” width=”290″ height=”249″ />A study conducted by Children’s Hospital Boston and the Joslin Diabetes Center has revealed that levels of “brown fat,” a healthy type of fat that appears in children, increase in puberty and then decrease after. The study also showed that thinner children have higher levels of brown fat. The study was published in the Journal of Pediatrics.

Researchers used PET scans to reveal the locations and concentrations of brown fat in children. Brown fat is unlike white fat in that it actually contributes to the burn-off of energy instead of functioning as an energy storage mechanism.

The study has important implications for fighting diabetes in children. “Increasing the amount of brown fat in children may be an effective approach at combating the ever increasing rate of obesity and diabetes in children,” said Aaron Cypess, MD, PhD. Cypess was the senior author of the paper in addition to being assistant investigator and staff physician at the Joslin Diabetes Center.

This is not Cypress’ first time investigating the role of brown fat in metabolism. His team showed in a 2009 study published in the New England Journal of Medicine that brown fat plays a role in the metabolism of adults as well. Prior to this study, it was accepted that brown fat appeared only in children and babies, but the study proved that brown fat is also found in between 3 and 7.5 percent of adults. Women have a greater chance of storing brown fat.

Cypess’ newest study involved PET scans of 127 children from ages 5 to 21. The researchers found active brown fat in 44 percent of the children; the incidence of brown fat was about the same for boys and girls. Children in the 13 to 15 year old range were most likely to have active brown fat stores, and theirs were the most active. The study also showed that BMI seemed to have an effect on the activity of brown fat: the heaviest children showed the least amount of brown fat activity.

Cypess’ previous study of brown fat in adults showed that brown fat stores were more active in the winter since it had to burn more energy to maintain homeostasis, or the “stabilization” of body temperature. The study of brown fat in children, however, showed that their brown fat stores were active at the same rate throughout the year. The authors of the study said that the decrease in brown fat activity from childhood to adulthood shows that it plays a role in the metabolism of children in addition to weight maintenance and energy balance.

“We believe that the ability to non-invasively evaluate brown fat activity in vivo with PET imaging provides a better understanding of its prominent role in pediatric physiology, and may possibly provide insights into the treatment of childhood obesity,” said Laura Drubach, MD, first author of the study and physician at the Children’s Hospital program in Nuclear Medicine and Molecular Imaging.

Cypess said that treating childhood obesity through this new knowledge would likely involve attempting to increase the activity of brown fat through non-pharmacological methods, such as by lowering the temperature in households or through the intake of certain foods. If those methods were not successful, medication may be necessary.

The Joslin Diabetes Center conducted a study in 2010 which showed that certain mice cells could be turned into brown fat cells. Cypess has hope that the studies will provide new answers in treating childhood obesity: “We might be able to combat the obesity and diabetes epidemics if we find safe ways of increasing brown fat activity. This might be an additional tool in the fight.”

The Journal of Sexual Medicine recently published a new study demonstrating that weight loss in men with Type 2 diabetes is more than just a healthy choice. It also improves sexual health, increasing erectile function and desire while lowering the risk of developing urinary tract symptoms.

The research team at the University of Adelaide, led by Professor Gary Wittert, MBBch, MD, FRACP, FRCP, conducted the study on 31 men who were diagnosed with Type 2 diabetes and classified as obese. The study lasted eight weeks and utilized two mechanics of weight loss: the men either ate a low-calorie diet based on meal replacements or a reduced carbohydrate, high protein, and low fat diet designed to decrease the patient’s nutritional intake by 600 calories a day.

The results of the study showed that even with just a 5 percent weight loss after eight weeks of the diet, the diabetic men demonstrated a decrease in sexual and urinary problems. The men’s’ sexual health continued to improve for a full year.

“Our findings are consistent with the evidence that not only erectile function, but also lower urinary tract symptoms are a marker of cardio-metabolic risk,” said Wittert. “The evidence that improvement can be achieved by modest weight loss, in particular when a diet is of high nutritional quality, is of public health significance in framing public health messages that resonate with men.”

Wittert hopes that framing weight loss in diabetic men as improving sexual function and health will be an effective wake-up call to men that they should work to lose weight. Since even a small amount of weight loss provides tangible benefits, Wittert believes that these findings will provide new data that will motivate men, especially those with diabetes, to take control of their weight loss and make a concerted effort.

“This important paper supports earlier publications that lifestyle is relevant and can positively affect sexual function,” said Irwin Goldstein, Editor-in-Chief of the Journal of Sexual Medicine, where the study was published. “At a time when oral drugs are very popular, it can now be shown that weight loss is an important non-pharmacologic therapeutic intervention in restoring erectile and urinary function and cardiovascular health,” continued Goldstein. “Obesity is an epidemic, and such data reinforce the positive relationship between eating right, losing weight, improved sexual function and voiding and overall cardiovascular health.”

According to the Harvard Medical School Joslin Diabetes Center, diabetes is commonly associated with sexual dysfunction in not only men but women as well. Thirty million American men experience impotence (or erectile dysfunction, the inability to achieve or maintain an erection); half of the 10 million American men diagnosed with Type 2 diabetes will suffer from impotence. Men with diabetes are two to three times more likely to suffer from impotence than non-diabetics. However, if a man’s diabetes is under control, he only has a 30 percent chance of suffering impotence.

Nerve damage is another risk factor in sexual for men with diabetes, with 50 to 70 percent of men with nerve damage experiencing impotence. Since sexual arousal occurs when a sexual stimulus causes the body’s autonomic nerves to signal more blood flow to the erectile tissue in the genitals, damage to the nervous system can impair this process and prevent the signals from ever reaching their destination.

The smell of that hamburger or steak (unprocessed meat) on the backyard grill is tantalizing, but we all know that we’re not supposed to have too much of it simply because it’s not great for our health for a number of reasons, to include the susceptibility to type 2 diabetes.  But, it’s now known that that hotdog (processed meat) lying beside that hamburger on the grill might be a little bit worse for your health than the burger or steak, including your susceptibility to type 2 diabetes.

A new study has shown that eating either unprocessed and/or processed meat can increase a person’s susceptibility to type 2 diabetes.  Processed meats are meats such as hotdogs, deli meats, bacon, or sausage.  Unprocessed meats are meats such as beef; in other words, that hefty steak on your plate that smells so good when it’s cooking.

But, the conclusion of this study indicates that the consumption of processed meats, which are usually high in sodium and nitrites, should be cut back dramatically, and that the intake of unprocessed red meat should be reduced.

The study was conducted at the Harvard School of Public Health and was led by An Pan, a Research Fellow in the Harvard School of Public Health’s Department of Nutrition.  The conclusion of this study will be published in the American Journal of Clinical Nutrition.

These study conclusions were cultivated from questionnaire responses that involved a long time period and a myriad of participants.  For 20 years, 37,083 men were followed in the Health Professionals Follow-Up Study; for 28 years, 79,570 women were followed in the Nurses’ Health Study 1; and for 14 years, 87,504 women were followed in the Nurses’ Health Study 11.  Included in the study’s conclusions were combined data from existing studies for a total of 442,101 participants, and 28,228 of those participants developed type 2 diabetes during the study; therefore, there were many, many people involved in these studies, and these study questionnaires covered a very long period of time.

The study concluded that one daily serving of 100 grams of unprocessed red meat (example:  steak, the size of a deck of cards) increased the percentage of a diagnosis of type 2 diabetes by 19 percent.  But, one daily serving of processed meats (example:  one hotdog) increased the percentage of a diagnosis of type 2 diabetes by 51 percent.

Senior author on the paper, Dr. Frank Hu, stated, “Clearly, the results from this study have huge public health implications given the rising type 2 diabetes epidemic and increasing consumption of red meats worldwide.”  Dr. Hu added, “The good news is that such troubling risk factors can be offset by swapping red meat for a healthier protein.”

There are many ways an individual can reduce their intake of unprocessed red meat, or that steak on your plate.  Unprocessed meats are also a big part of the backyard cookout, that famous hotdog on a bun, and it can also be swapped out for more nutritious food.

Red meat is high in protein, a necessity for the body to function properly, but protein can be found in many healthier choices.  An individual could use nuts instead of red meat on a number of occasions, switch to low-fat or fat-free dairy products, and increase one’s consumption of whole grains.  Fish is a great source of protein, as is legumes.  Nuts are a healthy option for protein, but are high in calories, so an individual would take that into account in their caloric intake for the day.

Over 25 million Americans have type 2 diabetes, which is usually controlled through diet restrictions, increased exercise, and medication, if necessary.  If left untreated, type 2 diabetes can lead to the same very serious complications of the body that type 1 diabetes causes, such as heart problems, kidney problems, vision problems and nerve problems (neuropathy).

“Our study clearly shows that eating both unprocessed and processed red meat – particularly processed – is associated with an increased risk of type 2 diabetes,” Pan stated.

This study result might make you pause a little in the supermarket and choose a salmon steak over a T-bone, scallops instead of that hotdog.  If a salmon steak isn’t to your taste, you can make salmon patties with canned salmon (good source of healthy protein) mixed with cooked brown rice (good source of whole grains), egg whites (more protein), and some grated onion and fresh ground pepper for zip.  You might even stick your nose in the air and breeze right past the processed foods case (baloney, hotdogs, bacon), and make a fat-free cottage cheese and egg white omelet instead.  Each little healthy food choice helps in the long run, but avoidance of known health hazards is a giant step in the right direction for healthy eating, which might lead to a longer and healthier life.

Support for this study was provided by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, and the National Heart, Lung and Blood Institute.

The heavy competition present in the modern insulins market has led to decreasing growth for Novo Nordisk, a Danish drug manufacturer. Novo Nordisk has found it more difficult to bring new products to the market due to the lack of growth in sales of modern insulin.

Despite being the world’s largest producer of insulin, Novo Nordisk shows a slowing of modern insulin sales. The company saw rising sales of diabetes treatment Victoza while modern insulin sales made up 43.6% of its total group sales for the second quarter of 2011.

The company expects full-year sales to rise by 11%, an increase over its earlier prediction of 8-10%. It also expects to see operating profits increase by 15-19% over its earlier prediction of 15%.

Jesper Brandgaard, Chief Financial Officer, expects sales of modern insulin to slow from quarter to quarter until a new product can be introduced. “All else equal, when you launch a new product you will have a fall in growth rates quarter by quarter, and the only way we can get growth going again is by launching a new product,” said Brandgaard. “We hope that degludec and degludec plus will come in and create new growth for our insulins in the United States.”

Brandgaard said that Novo Nordisk will soon be filing an application for registration of degludec in the U.S., although it could be a year to 18 months before the degludec is actually available to consumers. Brandgaard believes that degludec will become a “blockbuster,” or a drug that sells over $1 billion in a year.

Novo Nordisk blamed heavy competition from generic drugs in the oral anti-diabetic field. Healthcare reform across the world has also presented new challenges.

According to Swedbank analysist Johan Unnerus, “We expect modern insulin growth to slow ahead of approvals for the next generation of insulin, which will probably be late next year with the approval of degludec.” The approval of degludec will be a milestone for Novo Nordisk as both an ultra long-lasting insulin product and the premiere of the “next generation” of insulin.

Unnerus stated that the slow growth “leaves Novo a bit more exposed to any negative news or delays of degludec approval as the company faces slower growth.” Novo Nordisk has seen stiff competition from Sanofi-Aventis, manufacturer of Lantus.

Novo Nordisk saw its shares rise by 1.2% to 615 Danish crowns, though still trailing behind a previous high of 632 crowns.

Novo’s stock still beat out the European healthcare sector index and the Copenhagen bourse’s bluechip index, which rose 0.3% and 0.4% respectively.

Novo saw its earnings before interest and tax (EBIT) for the second quarter of 2011 reach over $1 billion, or 5.27 billion Danish crowns ($1.01 billion). Despite the growth, the numbers fell below the Reuters analyst estimate of 5.34 billion crowns. Novo’s second-quarter sales reached 16 billion crowns, which also placed it below analysts’ prediction of 16.57 billion for the quarter.

Victoza, Novo’s treatment for diabetes that stimulates the body into producing its own insulin, rose in sales by 322% to 1.25 billion crowns. That number eclipsed the analysts’ prediction of 1.22 billion.

Novo Nordisk’s sales of modern insulin rose by only 3% to 6.97 billion, falling far below predictions of 7.3 billion.

Two of Novo’s biggest competitors, AstraZeneca and Sanofi-Aventis, both raised their forecasts for 2011 revenues upon reporting their second-quarter earnings.

Boston Therapeutics has filed an abbreviated new drug application (or ANDA) with the Food and Drug Administration. The new drug appears in the form of chewable metformin, intended to help treat Type 2 diabetes.

The purpose of the medication is to aid in controlling blood sugar levels. It is to be used along with insulin or other medications for treating diabetes.

The CEO of Boston Therapeutics, David Platt, stated that this new medication complements Boston’s line of diabetes treatments. Boston also manufactures PZ-320, for management of blood glucose levels, and Ipoxyn, which treats limb ischemia.

According to chief technology officer Joan Sellers, Boston’s filing for this new ANDA represents a significant step in their diabetes treatment program.

Meals to Live has introduced a line of frozen meals specifically prepared by chefs for diabetics. This line of frozen meals will appear in grocery store freezers alongside other foods but is designed with the nutritional needs of diabetics in mind, offering diabetic-friendly foods such as Shrimp Jambalaya and Chili Relleno with Chicken and Ranchero sauce.

About 26 million Americans are currently living with diabetes and about 79 million have been diagnosed with pre-diabetes. Diabetics must take care when choosing their food as extreme blood glucose levels can be life-threatening. Meals to Live aims to alleviate the pressures on diabetics to choose healthy foods by presenting packaging with clear information about the nutritional value of its products, including sodium, fat, and fiber content. Meals to Live’s ultimate goal is to provide diabetic consumers with safe, healthy meal options that are just as convenient and easy to prepare as any other frozen meal. Meals to Live also offers several meals that are completely gluten-free.

Meals to Live was founded by Cole Egger. “After working with a number of diabetes support groups, I saw first-hand the frustrations these individuals face every day as they try to adhere to certain nutritional requirements and I was surprised to learn that there is nothing in the grocer’s freezer specifically for them,” said Egger, current CEO of Meals to Live. “Our meals provide a delicious, convenient alternative while meeting the nutritional needs of those living with diabetes, or anyone looking for flavorful, healthy meals.”

The diabetic-friendly Meals to Live can be found in grocery stores around the United States. Product carriers include Walgreens, Randall’s/Tom Thumb, Publix, Sprouts, Ralph’s, Raley’s, and Brookshire’s. The suggested retail price is $3.99 to $4.99. Customers can also purchase Meals to Live directly from the company’s website at mealstolive.com.

Cole Egger was motivated to introduce a line of diabetic-friendly frozen meals upon learning about the difficulties faced by a family friend in finding nutritionally sound food in a convenient and tasty package. Egger consulted with Jeremy Womble, chef for the Dallas Cowboys, in developing the line. Womble himself suffers from Type 2 diabetes.

Meals to Live’s line of entrees rate low in saturated fat, trans fat and sodium in addition to being high in fiber. Containing from 18g to 58g of carbohydrates, Meals to Live uses whole grains in its foods to provide low-GI energy that keeps diabetics active without causing swings in blood glucose.

Meals to Live also produces a diabetic-friendly product called Glucose Quick Sticks. These flavored powder packets dissolve quickly and provide a blood glucose boost for when low blood sugar strikes.

Learn more about Meals to Live by visiting http://www.mealstolive.com.

You may have seen him on Bravo TV’s “Top Chef,” but Sam Talbot now has his sights set on promoting Type 1 diabetes awareness. Talbot has joined “Life First,” a diabetes awareness campaign. Himself a Type 1 diabetic, Talbot seeks to increase awareness for diabetics in general and to stress that diabetics can lead full and active lives if they have access to blood glucose monitoring technologies.

“Many people view their diabetes as a barrier that prevents them from doing all the things they want to do,” Talbot said. “But instead of having diabetes be the focus of your life, ‘Life First’ means accepting your diabetes and taking control of it, every day, so that you can live your life on your terms.”

Talbot is an executive chef at Surf Lodge, located in Montauk, New York, in addition to being executive chef at Imperial No. 9, a restaurant in the Mondrian Soho Hotel. Talbot is familiar with the balancing act between managing diabetes and living a full and active life, and he intends to help other diabetics understand both the physiological and mental aspects of the disease, aiding them in managing their blood glucose levels as well as their outlooks and attitudes.

Sam Talbot seeks to be a driving force in the “Life First” campaign, relating his experiences with other diabetics and educating them on living successfully with the disease. There are approximately 26 million people in the United States living with diabetes.

Pharmaceutical company Kamada LTD. has been granted an Orphan Drug Designation for Alpha-1 Antitrypsin (AAT) product, which is used to treat Type 1 diabetes. Kamada LTD. specializes in the development, manufacture and marketing of special life-saving drugs and procedures.

Kamada’s new AAT must be subjected to a Phase I/II clinical trial. The AAT is administered by IV and has been approved by the FDA. “We are excited to enter the diabetes field and hope to bring a global breakthrough in the treatment of juvenile diabetes and potential cure,” said Kamada spokesperson David Tsur, Chief Executive Officer of Kamada.

Kamada will be publishing interim reports in 2012, or final reports if the trials are completed within that time frame.

The FDA approved Kamada’s AAT for treatment of Alpha 1 deficiency in July of 2010. The AAT is marketed in the United States by Baxter.

Type 1 diabetes causes the destruction of pancreatic beta cells, which produce insulin. Due to the reduction in insulin production, the body’s natural insulin levels must be altered so that glucose levels in the bloodstream do not enter dangerous territory. Diabetes treatments with AAT products are intended to reduce or prevent inflammation that destroys the pancreatic beta cells. It has been shown that although AAT is present in diabetics, it does not function at normal capacity.

The United States Juvenile Diabetes Research Fund states that there are 3 million cases of juvenile diabetes in the nation, with 30,000 new cases added each year.

According to the Centers for Disease Control, there are 10 million Type 1 diabetes patients worldwide with 100,000 new diagnoses added each year. The Juvenile Diabetes Research Fund of Israel states that 50,000 Type 1 diabetes cases are known in Israel with 200 new diagnoses each year.

Kamada is a publicly-traded (TASE: KMDA) pharmaceutical company that produces specialty medications and other therapeutics with chromatographic purification techniques. Kamada manufactures over 10 biopharmaceuticals which see distribution in over 15 countries.

Glassia, an FDA-approved pharmaceutical, is Kamada’s flagship product, marketed in the US by Baxter. Kamada is also developing an AAT by inhalation, which is undergoing Phase II/III trials in the EU. Five clinical trials of this inhaled AAT have already been concluded. Kamada will also soon undergo a Phase II/III trial of a rabies IgG treatment product in the US.

Smartphones have just become quite a bit more useful for diabetics and other patients who rely on regular injections of medication. A software engineering firm called Linxter, Inc. has begun to roll out a free phone application that keeps track of injections for patients with diabetes and multiple sclerosis, among other conditions which require frequent medication injections.

Linxter, Inc., based in Cooper City, Florida, began developing their TrackMyShots application after it was suggested by a friend with multiple sclerosis, according to CEO Jason Milgram. The app is designed to replace a patient’s injection logbook and will track the date, time, and location of injections.

The TrackMyShots application is freely available on the Windows Phone 7 platform. The Android app store will see the release of TrackMyShots in late August and iPhone users will be able to download the app in late September.

Visit http://www.trackmyshots.com for more information about the app.