Researchers Bioengineer Cells from Testicles to Produce Insulin

December 15th, 2010

Researchers have briefly "cured" Type 1 diabetes in lab mice using cells extracted from the testicles of deceased human donors. The spermatogonial cells used in the experiment normally produce sperm in men. Scientists extracted them from the donors, bioengineered them to act like the beta cells in the pancreas that produce human insulin, and transplanted them into mice. The transplanted cells successfully secreted insulin, reducing blood sugar levels in the mice for about a week.

While exciting, the breakthrough doesn't yet amount to a cure for insulin dependent diabetes in humans. "These cells don't secrete enough insulin to cure diabetes in humans yet," cautions the study's senior researcher G. Ian Gallicano, an associate professor at Georgetown University Medical Center. However, Gallicano is hopeful that transplanting the spermatogonial cells into different parts of the body may lead to longer blood sugar control. "We know spermatogonial stem cells have the potential to do what we want them to do," says Gallicano, and we know how to improve their yield."

The researchers chose to work with spermatogonial cells because they behave a lot like human eggs, and can be chemically instructed to behave like embryonic stem cells. Stem cells are unspecialized or "undifferentiated" cells that have the potential to develop or differentiate into many different types of cells.

Earlier attempts to transplant insulin-producing beta cells (also called islet cells) found in the pancreas achieved some success, but islet cells transplants are handicapped by the body's autoimmune system's attempts to destroy the new tissue, which it sees as an invader. While they no longer require diabetes medication, islet cell transplant recipients must take powerful immunosuppressive drugs with undesirable side effects, including an increased risk of infection and cancer. A major benefit of spermatogonial cell transplants is that they avoid arousing an auto-immune response.

One obvious disadvantage is that the procedure can only be performed in males, although the fundamental approach might be applicable to the female counterpart of sperm-producing cells, oocytes. Another concern is the potential for spermatogonial cell transplant recipients to develop a type of tumor called a teratoma, associated with the abnormal development of germ (reproductive) cells. But Gallicano is convinced that it would take many more spermatogonial cells than would be required to produce insulin to cause such a tumor.

Gallicano and his fellow researchers are hopeful that they've taken the first step towards reducing diabetic hyperglycemia in humans and eliminating the need for diabetes drugs. This gives hope to the almost 24 million Americans with diabetes, one of the leading causes of death in the US. There are two main types of diabetes: type 1, which requires lifelong insulin injections; and the much more common type 2, which can be controlled by diet, exercise, and, if needed, oral diabetes medication. Both types must be managed carefully to avoid serious complications.

Insulin Producing Cell Pouch Approaching Clinical Trials in Humans

January 7th, 2011

A Canadian health sciences company focusing on innovative medical technology has successfully tested an organ-like device containing insulin producing islet cells in animals, and is pursuing FDA approval to conduct clinical trials in humans in 2011. There were no adverse side effects associated with the device during the study, during which the diabetic pigs receiving the insulin delivery system achieved long-term blood sugar control.

Sernova Corporation's patented Cell Pouch System is implanted under the skin, where it develops into what the company refers to as "a tissue engineered pancreas" when infused with islet cells. The islet cells deliver insulin to the body, much as the islet cells of the pancreas do in people and animals without insulin dependent diabetes.

Current islet cell transplantation involves removing insulin-producing cells from a donor pancreas and transferring them through a needle directly into the liver of a person with diabetes. The technology is still considered experimental, and is hampered by the body's immune system, which sees the insulin producing cells as foreign invaders and attempts to reject them. The Cell Pouch protects the cells from the immune system, eliminating the need for powerful anti-rejection drugs, which often have serious side effects. The Cell Pouch would be less costly, and requires only about 10% of the insulin producing islets used in the existing islet cell transplant technique.

According to the American Diabetes Association, diabetes is the sixth leading cause of death in the US. The number of American adults diagnosed with diabetes has more than doubled over the past decade, rising from 9 million to 19 million, largely because of soaring obesity rates. While they are more effective, the newer diabetes medications can cost as much as ten times more than the older generic diabetes drugs. Given the option to both save money and avoid daily insulin injections, most diabetics would welcome the option of the new Cell Pouch.

Sernova Corporation says its Cell Pouch System has the potential to treat a wide range of conditions besides insulin dependent diabetes, including Parkinson's disease, spinal cord injury, and hemophilia.

Experimental Weight Loss and Diabetes Drug in Clinical Trials

April 19th, 2011

overweight male
Diabetes and obesity are closely linked, and many diabetics struggle to follow their doctor's orders to lose weight. The biopharmaceutical company Vivus hopes to market an investigational new drug, Qnexa, as both a weight loss drug and a diabetes medication.

Qnexa is in phase 3 clinical trials to treat obesity, and in phase 2 clinical development for the treatment of type 2 diabetes and sleep apnea. The most recent clinical trial of Qnexa as a weight loss drug resulted in an average 10 percent weight loss in study participants.

Qnexa is a combination of the appetite suppressant phentermine, (best known as the "phen" in fen-phen, a controversial weight loss drug that was pulled off the market in 1997), and the anticonvulsant topiramate, prescribed to treat epilepsy and prevent migraine headaches.

Qnexa was denied approval in late 2010, when the FDA expressed concerns about a slightly increased risk of adverse psychiatric and cardiovascular events, and questioned the possibility of birth defects in pregnant women taking the drug.

More than 2400 patients took part in the latest study. Study participants were all clinically obese, and also suffered from two or more secondary medical conditions such as diabetes or heart disease. Patients also saw improvements in high blood pressure, cholesterol and A1C levels (glycated hemoglobin). High A1C levels indicate high levels of blood glucose in diabetics.

Shares of Vivus have increased up to sixteen percent in value since the latest study results were released. If approved, Qnexa would be the first new weight loss drug on the market in more than ten years. Currently, the only FDA approved prescription weight loss drug is orlistat (Zenical). Orlistat prevents the body from absorbing the fat in food, and is known for unpleasant side effects such as loose, oily stools, fecal incontinence and flatulence.

A second weight-loss drug manufacturer, Orexigen, is also struggling to get FDA approval for their new diet drug, Contrave. Contrave is a combination of bupropion (the antidepressant Wellbutrin, also marketed as the smoking cessation aid Zyban) and naltrexone, an opiate antagonist prescribed to treat narcotic and alcohol addiction. Contrave is designed to curb food cravings, and proved effective than Qnexa in terms of weight loss.

Contrave passed a major hurdle in late 2010 when an FDA advisory committee voted 13-7 for its approval, but the FDA disagreed in early 2011, asking for a new clinical trial evaluating the drug's cardiovascular risks.

Arena Pharmaceutical's Lorcaserin was the third diet drug to fail to win FDA approval in 2010, when the FDA deemed that safety concerns outweighed the drug's "marginal effectiveness".

FDA Approves New Type 2 Diabetes Medication

May 4th, 2011

diabetes medicationThe FDA has approved a new oral diabetes medication, Tradjenta (linagliptin) to help control blood glucose in type 2 diabetics. Tradjenta works by blocking the enzyme dipeptidyl peptidase-4 (DPP-4), resulting in increased levels of hormones which stimulate the release of insulin after eating.

Tradjenta was tested in almost 4000 diabetics in eight separate double-blind clinical studies. It was studied both by as a stand-alone therapy, and in combination with other current diabetes medications such as glimepiride, pioglitazone, and metformin. It has not been tested along with insulin injections, and is not recommended for use by insulin dependent type 1 diabetics.

Tradjenta is meant to be used along with diet and exercise. People with diabetic ketoacidosis (high levels of ketones in the blood or urine) are cautioned not to use linagliptin. People taking the antibiotic rifampin, used to treat tuberculosis, should also avoid Tradjenta. The most common side effects of linagliptin were nasal congestion or a runny nose, sore throat, upper respiratory infection headache, and muscle pain.

An estimated 24 million Americans have diabetes, and up to 95 percent of them have the most common form, type 2. People with Type 2 diabetes either can't produce or are resistant to the effects of insulin, a hormone produced by the pancreas which regulates blood sugar. A lack of insulin or insulin resistance lead to high blood sugar levels, which can cause serious, and even life threatening, complications.

Some type 2 diabetics can control their blood sugar with diet and exercise, but many require oral diabetes medication or even insulin injections. The existing diabetes medications Januvia and Onglyza are also DPP-4 inhibitors. While all in the same class, the three diabetes drugs appear to have significant differences in effect, making it important that non insulin dependent diabetics have yet another option to successfully control their blood sugar.

The new diabetes medication is the first of its class to be approved at one dosage strength (5 mg) for all patients, including those with kidney or liver impairment. In another first, the diabetes drug is marketed by an alliance of Boehringer Ingelheim Pharmaceuticals Inc in Connecticut, and Eli Lilly in Indianapolis.

Type 1 Diabetics Respond Well to New Type 2 Diabetes Medication

June 8th, 2011

Type 1 diabetics given a recently approved type 2 diabetes medication in addition to their insulin therapy experienced a "dramatic change" in their health. They had more stable blood sugar levels, needed less insulin, and even lost an average ten pounds over six months.

The FDA approved Victoza as a once-daily injection to treat type 2 non insulin dependent diabetes in adults in early 2010. Although it is injected, Victoza is not a type of insulin. Victoza (generic name liraglutide) belongs to a new class of medications called glucagon-like peptide-1 (GLP-1) receptor agonists.

GLP-1 receptor agonists mimic the action of a natural peptide which helps the pancreas to make more insulin after a meal. They also slow the absorption of sugar in the stomach, act as an appetite suppressant, and lower levels of glucagon, a hormone which counteracts the effect of insulin.

Researchers at the State University of New York conducted a clinical study with 14 type 1 diabetics whose blood sugar was well controlled using an insulin pump. Although their insulin therapy was effective, all the study participants showed unpredictable peaks and dips in their blood sugar levels.

When Victoza was added to their insulin therapy, all 14 saw their blood sugar quickly stabilize. Within a week, their fasting and blood sugar levels fell an average 15 percent. The longer they took Victoza, the less insulin they required. Both their mealtime and all-day insulin dosing lowered about 30 percent. Those that continued in the study for six months experienced even less need for insulin.

Lowering the levels of insulin suppressing glucagon appears to be of much more benefit to type 1 diabetics than had been anticipated. "Over a protracted period of time, as their diabetes continues to be well controlled, there is delightful improvement in patients' well being," says study leader Dr. Paresh Dandona.

Prescription Byetta (generic name exenatide) is a similar GLP-1 receptor agonist also recently approved by the FDA. Exenatide mimics the action of incretin hormones to lower blood sugar. Byetta is injected twice daily. Byetta has not yet been tested in type 1 diabetes, but the researchers believe both type 2 diabetes drugs would have the same effects.

Both liraglutide and exenatide are normally prescribed in combination with diet, exercise, and other diabetes medication. Neither Victoza or Byetta are FDA approved for use in type 1 diabetes, and Dandona advises that they should only be prescribed off-label by an endocrinologist specializing in diabetes treatment. Dandona is pursuing funding for a larger study.

Poor Sleep in Diabetics Leads to 82% Higher Insulin Resistance

June 13th, 2011

man in bed

There are complex cause and effect relationships between sleep and diabetes. Poor sleep is considered a risk factor for diabetes, while diabetes is considered a contributor to poor sleep.

Sleep disorders such as insomnia, excessive snoring and obstructive sleep apnea are more common in people with type 2 diabetes. As a result, many diabetics don't sleep as well as people without the disease.

Recently, researchers conducting a study titled Cross-Sectional Associations Between Measure Of Sleep And Markers Of Glucose Metabolism Among Persons With And Without Diabetes" monitored the sleep patterns of 40 type 2 diabetics over six nights. They were first interviewed about their normal sleeping patterns, and blood samples were taken to measure their glucose and insulin levels.

Participants wore activity monitors on their wrists to measure their movements through the night. A poor sleep was defined by both the data from the wrist monitors, and the patient's description of how long it took them to fall asleep and how many times they woke up through the night.

The poor sleepers had significantly higher blood glucose levels in the morning - 23 percent higher than those who got a restful sleep. Even more striking, their blood insulin levels were 48 percent higher. The researchers crunched the two numbers to calculate that poor sleepers with diabetes had 82% higher insulin resistance than diabetics who were able to get a good sleep.

"Poor sleep quality in people with diabetes was associated with worse control of their blood sugar levels," said the study's lead author, Kristen Knutson, PhD, an assistant professor of medicine, "people who have a hard time controlling their blood glucose levels have a higher risk of complications. They have a reduced quality of life. And they have a reduced life expectancy."

The logical next step, according to the researchers, is to see if improving the quality of sleep in diabetics can help them lower insulin resistance give them better long term diabetes control and improve their quality of life.

"This suggests that improving sleep quality in diabetics would have a similar beneficial effect as the most commonly used anti- diabetes drugs," said Eve Van Cauter, PhD, professor of medicine and co-author of the study, which was recently published in Diabetes Care.

The researchers also want to solve the "chicken and egg" aspect of chronic poor sleep and chronic insulin resistance, and determine which leads to the other. In the meantime, they're suggesting that diabetics with insomnia add sleep treatment to their diabetes medication.

FDA: Long-Term Use of Actos May Be Associated With Bladder Cancer

June 17th, 2011

The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

This safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study1, described in FDA's September 2010 ongoing safety review and in the Data Summary. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

To read the Safety Announcement on the FDA website, >CLICK HERE.<

Swamp Gas Plays a Role in Diabetes Control

August 9th, 2011

The last decade has been an exciting time in diabetes research, with scientists approaching diabetes control from many different angles. Enter hydrogen sulfide, the foul smelling gas better known as "swamp gas". It turns out the sewer-scented compound, a substance that occurs naturally in our bodies, may play an important role in protecting blood vessels from diabetic complications.

In a finding that they say "may open the door for new therapies", researchers discovered that providing cells with high levels of hydrogen sulfide protected them against the toxic effects of sugar.

To read the full story on diabeticlive.com, a news publication focused on the latest research in diabetes drugs, diets, and medical advances, >CLICK HERE.<

Diabetes Videos on WebMD

August 18th, 2011

More and more people are turning to the web for information on health issues, including diabetes. WebMD is one of the most highly respected sources of timely and trusted medical news and information on the web. The site's Health A to Z section includes a comprehensive Diabetes Health Centre sub-section.

Aware that many people prefer to get their information in other ways rather than reading, WebMD has incorporated a number of alternative means of delivering information into their site, including interactive quizzes, tools such as a Food & Fitness Planner, and short documentary-style videos.

The diabetes-related videos feature real people in real life settings - diabetes patients, parents of diabetic children, researchers, and health care professionals. Currently, the site contains sixty diabetes videos on diverse topics, including:

  • Basic diabetes information (type 1 diabetes, type 2 diabetes, pre-diabetes, diabetes diagnosis, diabetes control, diabetes medication-)

  • Diabetes management (diet, foot care, glucose monitoring, A1C testing, hypoglycemia and hyperglycemia-)

  • Diabetes in children (preschool, young children, adolescents-)

  • Insulin delivery methods (insulin pumps, insulin inhalers, islet cells transplant-)

  • Diabetes research and studies (diabetes vaccine, stem cells, investigational diabetes medications, glucose monitoring tattoo, cord blood study-)

  • New diabetes treatments (islet cells transplant, continuous glucose monitors, botox for foot wounds, silicone eye oil for retinopathy-)

  • Alternative diabetes treatment (vinegar for diabetes, antioxidants, hyperbaric oxygen, medicinal properties of kudzu-)

  • Diabetes complications (foot ulcers, diabetic retinopathy, diabetic neuropathy, diabetes and depression, kidney disease-)

Should a topic be of particular interest, every video is surrounded by links to related in-depth information. To view a WebMD Diabetes Health Centre video on a study on the use of vinegar as a diabetes medication >CLICK HERE.<

Discovery of Pancreatic Insulin Switches Could Lead to New Diabetes Drugs

October 19th, 2011

Researchers at the Salk Institute have discovered how a hormone turns on a series of molecular switches inside the pancreas that increases the production of insulin. The finding, published in the Proceedings of the National Academy of Sciences, raises the possibility that new designer diabetes drugs might be able to turn on key molecules in this pathway to help the 80 million Americans who have type 2 diabetes or pre-diabetic insulin resistance.

The molecular switches command pancreatic beta islet cells, the cells responsible for insulin, to grow and multiply. Tweaking these cells might offer a solution to type 1 diabetes, the form of diabetes caused by destruction of islet cells, and to type II diabetes, the form caused by insulin resistance.

"By understanding how pancreatic cells can be encouraged to produce insulin in the most efficient way possible, we may be able to manipulate those cells to treat or even prevent diabetes," says the study's lead author, Marc Montminy, a professor in the Clayton Foundation Laboratories for Peptide Biology at Salk.

To read the full article on ScienceDaily, >Click Here.<