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Thread: Diabetes advances, research & treatments

  1. #11
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    Is it really useful?...

    FDA staff question utility of Novo Nordisk combo diabetes drug
    May 20, 2016 - A preliminary review by the U.S. Food and Drug Administration of Novo Nordisk A/S's experimental diabetes drug, IDegLira, questioned the interpretability of the study findings and practical use of the treatment, according to a review posted on the agency's website on Friday.
    The review comes ahead of a May 24 meeting of an FDA advisory panel that will discuss the drug and make recommendations as to whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does. The drug combines Novo's drug Tresiba, known also as insulin degludec, with its GLP-1 agonist Victoza, known also as liraglutide. The company is seeking FDA approval for the combination product, IDegLira, to improve glycemic control in adults with type 2 diabetes. The drug was approved in Europe in 2014 under the brand name Xultophy.

    On May 25 the advisory committee will consider a similar drug, Sanofi SA's iGlarLixi, which combines the company's experimental GLP-1 agonist lixisenatide with its insulin treatment Lantus, also known as insulin glargine. The two companies' products would be the first to combine a GLP-1 and a basal insulin in a single injection. The idea is to treat patients earlier with a combination drug rather than waiting for patients to lose control of their blood sugar on one drug before moving to another. In its review of Novo Nordisk's drug, the FDA said, "The enhanced convenience that derives from combining two products into one dosage form generally comes at the cost of loss of dosing flexibility."


    Employees stand in the insulin production plant of Danish multinational pharmaceutical company Novo Nordisk in Chartres, north-central France

    The FDA reviewers found no new safety issues with IDegLira that were not already known for degludec and liraglutide but said, "It is important to note that use of IDegLira would expose patients to safety risks associated with both products." The reviewers also said the use of IDegLira allows for lower doses of liraglutide than have been proven efficacious while incurring safety risks associated with liraglutide use. The reviewers said there were limitations with the clinical trials that make the results difficult to interpret.

    Diabetes is a chronic metabolic disorder characterized by abnormally high blood sugar levels that can lead to blindness, heart disease and other serious conditions. Lixisenatide was approved by regulators in Europe and Japan in 2013 and is sold under the brand name Lyxumia. Sanofi licensed lixisenatide from Denmark's Zealand Pharma A/S.

    https://www.yahoo.com/news/fda-staff...ce.html?ref=gs
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    FDA targets sugar in new labeling rules
    May 20, 2016) - The U.S. Food and Drug Administration said it would update guidelines for nutritional labels on packaged food and beverages to include information on added sugar and to prominently display calorie count and servings.
    The move comes at a time the United States is staring at increasing childhood and adult obesity and lifestyle diseases such as heart problems. The FDA said on Friday that the modified guidelines, which companies would have to adopt within two years, would help consumers "make informed decisions about the foods they eat and feed their families." (http://1.usa.gov/1ODAIin) "What and how much people eat and drink has changed since the last serving size requirements were published in 1993," the FDA said.

    Currently, companies are required to provide details on the total amount of sugar in a product. Under the modified guidelines, they will have to break down details on the amount of added sugar such as corn syrup and white and brown sugar.

    Information about "Calories from Fat" will be removed because research shows the type of fat is more important than the amount, the FDA said. According to Centers for Disease Control and Prevention, more than a third of U.S. adults are obese. First Lady Michelle Obama, who has used her White House position to launch the "Let's Move" campaign to fight childhood obesity, had called for the changes two years ago.

    https://www.yahoo.com/news/fda-modif...or.html?ref=gs
    Last edited by waltky; 05-20-2016 at 10:15 AM.

  2. #12
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    Diabetes link to cancer in Asia...


    Study: Diabetes Linked to Cancer in Asia
    March 07, 2017 - Researchers at New York University's School of Medicine found that diabetes increased the risk of cancer death among Asians by an average of 26 percent, a statistic similar in the West.
    Data for the new study drew on an analysis of 770,000 people with Type 2 diabetes throughout East and South Asia. Diabetics were followed for an average of 13 years to see if they developed cancer and what types. During that time more than 37,300 cancer deaths were identified. Yu Chen, an epidemiology professor at the NYU School of Medicine’s Department of Population Health who was the study's lead author, says Asians with Type 2 diabetes are more likely to be diagnosed with rarer cancers than Westerners, including cancers of the liver, thyroid and kidney which was double the risk compared to non-diabetics in Asia.


    There was also a 2.7 percent increased risk of cancer of the endometrium and a 1.7 percent higher risk of breast cancer among diabetic Asians compared to those who were not diabetic. The number of cancers of the gallbladder and bile ducts in Asia were comparable to those in the West, according to Chen. Those sites are closer in the body to the pancreas, where insulin is made.



    A paramedic checks the blood sugar level of a patient at a diabetes clinic in Jakarta, Indonesia



    Chen thinks there may be several mechanisms at work, but data suggests that insulin may in some way stimulate the growth of cancer. “Patients with diabetes that have high levels of insulin, some cancers are very sensitive to insulin, so it may promote the tumor growing,” she said. The findings were published in the journal Diabetologia.


    Chen said the study was undertaken because there's been little research on an association between diabetes and cancer in Asia. She said the research suggests Type 2 diabetes should be added to the list of cancer risk factors, along with diet and cigarette smoking. “Cancer prevention needs to take into account for diabetes the lifestyles related to diabetes – [which] may reduce the risk of diabetes and also cancer,” she said. Chen suggested that diabetics should receive more cancer screenings, in addition to medical interventions to reduce the risk of diabetes overall.


    http://www.voanews.com/a/diabetes-ca...a/3754817.html

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    Researchers Develop Blood Test to Pinpoint Location of Cancer
    March 07, 2017 - Researchers are developing a blood test that can tell not only whether someone has cancer, but in what organ the tumors are lurking. The test could mean more prompt, potentially life-saving treatment for patients.
    Researchers describe their blood test as a kind of dual authentication process. It is able to detect the presence of dying tumor cells in blood as well as tissue signatures, to signal to clinicians which organ is affected by the cancer. There already are tests that screen for traces of DNA released by dying cancer cells. Such blood tests show promise in the treatment of patients to see how well anti-cancer therapies are working. But researchers at the University of California, San Diego discovered a new clue, using organ-specific DNA signatures, that leads them to the particular organ that is affected.


    The finding makes the new blood test potentially useful as a screening tool in people suspected of having cancer. UC-San Diego bioengineering professor Kun Zhang is senior author of a paper in Nature Genetics about the experimental test. "So when you try to do these kinds of early screening or early detection [tests], these people are healthy. So if you take a blood draw and then you do a test, and you find some signature of cancer, that is not enough because you do not know what to do next," Zhang said. "And so, in this case, we developed a method where we can say whether there is a cancer growing in the body and if the answer is 'Yes,' we can also say something about where does it grow."



    A patient has her blood drawn at Jefferson University Hospital in Philadelphia, Pennsylvania



    The test screens for a DNA signature called a CpG methylation haplotype, which is unique for each tissue in the body. When a cancer grows in an organ, it competes with healthy tissue for nutrients and space, killing off healthy cells, which release their DNA into the bloodstream. The haplotype signatures, identified by the blood test, could tell doctors what cells are being destroyed, and therefore what organ is being invaded by cancer. Zhang says knowing a tumor's location is especially crucial for early detection and treatment.


    Researchers created a database of complete CpG methylation patterns for 10 different normal tissues: the lungs, liver, intestine, colon, brain, pancreas, spleen, stomach, kidney and blood. To put together the genetic marker database, the investigators also analyzed tumor and blood samples of cancer patients. They screened the blood samples of 59 patients with lung or colorectal cancer, comparing those findings to people without cancer. "It could be potentially used as a screening test," Zhang said. "So I think that is the real potential. We need to do a few more rigorous clinical observations before we can get to that point." Zhang envisions eventually using the blood test to look for markers of cancer as part of routine blood work.


    http://www.voanews.com/a/researchers...r/3754822.html
    Last edited by waltky; 03-07-2017 at 11:51 PM.

  3. #13
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    Sniffing out hypoglycemia...

    Dogs Trained to Monitor Low Blood Sugar May Save Lives
    May 07, 2018 — Dogs can be trained to sniff out drugs and explosives, so Mark Ruefenacht wondered if their exquisite sense of smell could be used to detect changes in a diabetic’s blood sugar level.
    A near fatal episode prompted the forensic scientist, who’s had diabetes for most of his adult life, to ask that question. In 1999, while he was training a puppy to be a guide dog for the blind, his blood sugar suddenly dropped to a dangerously low level. “More than likely, I had a seizure, from the low blood sugar,” Ruefenacht recalled, as he explained how the puppy kept trying to rouse him. “And he stuck with me and I was able to get my blood sugar up.” That incident made him wonder if dogs could be trained to detect the inherent chemical changes that accompany a drop in blood sugar, called hypoglycemia, then alert their owners.


    Dogs4Diabetics


    Ruefenacht worked with scientists and funded research which determined that the “smell” of hypoglycemia shows up in both breath and sweat. He also worked with and studied professionals who train dogs to sniff out everything from explosives to cancer. And most important of all, Ruefenacht started training a fun-loving yellow Labrador retriever named Armstrong to alert him when he was having a dangerously low blood sugar. The training proved so successful, Armstrong is listed in the Guinness Book of World Records as the first diabetes-detection dog. Sitting under a poster of Armstrong, who died in 2012, Ruefenacht recalls that those early successes led some organizations to offer him large sums of money for the rights to his discoveries. Ruefenacht says he turned those opportunities down. Instead, in 2004, he founded Dogs4Diabetics. He says properly training a diabetes detection dog and its owner can cost $50,000. The organization raises money to cover these expenses, then provides the dogs at no cost to people who qualify.


    The smell of hypoglycemia


    The dogs are trained to identify the scent of hypoglycemia on a reliable and consistent basis. Ruefenacht uses jars containing swabs of sweat from a diabetic who had low blood sugar, randomly mixed with jars of other distracting smells, such as peanut butter, dog food and eucalyputus. The dogs are rewarded when they select the correct jar. This "sweat jar" method for training diabetes alert dogs has been validated scientifically. The next step is to teach them to alert their owner. The dogs are trained to use subtle signals, but if those go unnoticed, to put their paws on his lap, or balance on their back legs and put their front paws on his shoulders. They learn to snuffle at his nose and mouth, lick his face and bark. And if all else fails, they’re trained to get someone else to come and help.



    Mark Ruefenacht and Armstrong, the first diabetes alert dog.


    Ruefenacht says the dogs are often aware of blood sugar drops long before electronic monitoring systems send a warning alarm. Dogs4Diabetics has placed more than 100 dogs with diabetics. They hope to expand the program - training humanity's most loyal companion to save lives and help diabetics around the world.


    https://www.voanews.com/a/dogs-for-d...s/4382782.html

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