Onset Of Type 1 Diabetes Not Prevented By Oral InsulinCrucial Findings Aid Understanding Of Diabetes< June 18, 2003 >Insulin taken orally does not delay or prevent type 1 diabetes in people at moderate risk (25 percent to 50 percent likelihood) of developing type 1 diabetes in five years, says a report from the annual meeting of the American Diabetes Association (ADA). The results came from the second trial conducted as part of the Diabetes Prevention Trial-Type 1 (DPT-1), which ended last month. The other DPT-1 trial, completed two years ago, found that low-dose insulin injections failed to prevent or delay type 1 diabetes in people at high risk (50 percent or greater chance) of developing the disease in five years. About 17 million people in the US have diabetes, the most common cause of blindness, kidney failure, and amputations in adults and a major cause of heart disease and stroke. About 1 million have type 1 diabetes. Formerly known as juvenile onset or insulin-dependent diabetes, type 1 diabetes usually begins in children and adults under age 30. It develops when the body’s immune system attacks the insulin-producing cells of the pancreas. Results the Same for Both Groups StudiedA total of 372 people took part in the trial comparing the rate of progression to type 1 diabetes in two groups - those taking a daily capsule of insulin crystals (7.5 mg.) or those taking an inactive substance, the researchers report. All participants had a 25 percent to 50 percent chance of developing type 1 diabetes in the next five years, a calculation based on genetic, immunologic, and metabolic tests done before enrollment. Upon joining the trial, which began in 1996, all participants were making normal amounts of their own insulin. Their ages ranged from 3 to 45 years old. After an average of 4.3 years of observation, about 35 percent of people developed type 1 diabetes in each group. The annual rate of onset (7.2 percent per year) was nearly the same in both groups. Testing done as part of the study detected most cases of diabetes before symptoms developed, enabling patients to get prompt, early treatment. No side effects were linked to oral insulin. “This result is very disappointing, but it’s important to remember that negative findings also provide important scientific answers,” said study chair Dr. Jay Skyler of the University of Miami. “We’ve learned a great deal from both DPT-1 trials about the natural history of type 1 diabetes and the immune events that underlie it, and that knowledge is crucial to future prevention efforts.” Screening Can Predict Risk for DiabetesAlthough oral insulin did not prevent or delay diabetes, the study confirmed and expanded on the observations made in the low-dose insulin injection trial that the risk of developing diabetes can be predicted by participants' characteristics and lab tests performed during screening. The oral insulin study was based on the hypothesis that insulin taken orally might suppress the immune system’s destructive attack on beta cells. The oral insulin trial is the third large study that failed to prevent type 1 diabetes in at-risk people. The European Nicotinamide Diabetes Intervention Trial (ENDIT) also failed to prevent or delay type 1 diabetes with nicotinamide, a vitamin present in small amounts in a normal diet. “The findings of these trials underscore how much we still have to learn about the underlying immune events that lead to type 1 diabetes,” said Dr. Judith Fradkin, director of the Division of Diabetes, Endocrinology, and Metabolic Diseases in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “We plan to closely follow people at risk to try to understand the disease better and to find ways to stop the complex autoimmune process that leads to type 1 diabetes," Dr. Fradkin says. "We will also be testing approaches to preserve the ability to make insulin in people with newly diagnosed type 1 diabetes.” Upcoming clinical trials will be conducted under Type 1 Diabetes TrialNet, a collaborative network of clinical centers dedicated to preventing type 1 diabetes and preserving insulin production in new-onset patients. The first trials are scheduled to begin enrolling patients in the fall of 2003. Always consult your physician for more information. How Do Type 1 and Type 2 Diabetes Differ?Although type 1 and type 2 diabetes are similar in the build-up of blood glucose due to problems with insulin, there are differences in cause and treatment: type 1 diabetes type 2 diabetes Online Resources(Our Organization is not responsible for the content of Internet sites.) Centers for Disease Control and Prevention (CDC) National Diabetes Education Program |
For more information on health and wellness, please visit health information modules on this Web site. Aspirin as Effective as Standard Drug in Preventing Stroke in African AmericansResults from the African American Antiplatelet Stroke Prevention Study (AAASPS) show that aspirin is as effective as ticlopidine (a type of clot inhibitor) for the prevention of a second stroke in this group. The study, sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), is reported in the Journal of the American Medical Association (JAMA). This clinical trial looked at 1,809 African-American stroke patients participating in one of 60 study sites in the US. African Americans are at about twice the risk of experiencing a stroke or dying from a stroke, compared to Caucasians. This group has a higher prevalence of stroke and cardiovascular disease risk factors such as hypertension, diabetes mellitus, obesity, and cigarette smoking. The AAASPS was stopped early after analyses suggested that there was less than a 1 percent chance that ticlopidine would be shown to be superior to aspirin if the study were carried to completion. "The study shows that aspirin is probably a better choice than ticlopidine for recurrent stroke prevention in African Americans," said Dr. John R. Marler, associate director for clinical trials research at NINDS. "For those who can tolerate it, aspirin is readily available, inexpensive, and easy to administer," Dr. Marler says. "Ticlopidine, on the other hand has the potential for serious side effects." The FDA approved ticlopidine, for clinical use in the early 1990s to reduce the risk of fatal or non-fatal stroke in patients with stroke risk factors, and in patients who had a completed thrombotic stroke. AAASPS study participants were enrolled between one week and 90 days after the occurrence of an ischemic stroke. Volunteers were assigned daily doses of either 650 mg of aspirin or 500 mg of ticlopidine. "We are encouraged to have such a large number of African Americans in a clinical trial on stroke," said Dr. Audrey S. Penn, acting director of the NINDS. "This study showed that with careful planning and sensitivity to community concerns we were able to recruit a large number of African Americans and safely follow them through an important clinical trial initiative such as AAASPS." The study was led by Dr. Philip B. Gorelick, of the Center for Stroke Research at Rush Medical College in Chicago. Always consult your physician for more information. What Is Stroke?Stroke occurs when blood flow to the brain is disrupted. Disruption in blood flow is caused when either a blood clot blocks one of the vital blood vessels in the brain (ischemic stroke), or when a blood vessel in the brain bursts, spilling blood into surrounding tissues (hemorrhagic stroke). The brain needs a constant supply of oxygen and nutrients in order to function. Even a brief interruption in blood supply can cause problems. Brain cells begin to die after just a few minutes without blood or oxygen. The area of dead cells in tissues is called an infarct. Due to both the physical and chemical changes that occur in the brain with stroke, damage can continue to occur for several days. This is called a stroke-in-evolution. A loss of brain function occurs with brain cell death. This may include impaired ability with movement, speech, thinking and memory, bowel and bladder, eating, emotional control, and other vital body functions. Recovery from stroke and the specific ability affected depends on the size and location of the stroke. A small stroke may result in only minor problems such as weakness in an arm or leg. Larger strokes may cause paralysis (inability to move part of the body), loss of speech, or even death. Always consult your physician for more information. |
