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Type 2 diabetes trials give patients hope

Katy Wiley and her son, Kyle. Katy Wiley

Katy Wiley and her son, Kyle. Katy Wiley began her struggle with Type 2 diabetes when she was pregnant in 1990. Photo Credit: TNS / Katy Wiley

Katy Wiley began her struggle with Type 2 diabetes in 1990, when she was pregnant with her second child. The disease progressed, and at eight weeks she started insulin treatment, hoping that once her son was born, the diabetes would disappear. Instead, her condition steadily declined.

Vision problems and nerve damage, common complications of diabetes, began to appear. Her A1C blood glucose (sugar) levels were increasing, she was at least 50 pounds overweight, and the medication metformin had been added to her daily therapy routine of insulin injection. That’s when she read about a Type 2 diabetes study at Cleveland Clinic that was recruiting patients to participate in one of three arms of treatments to study the effectiveness of methods to treat and possibly reverse Type 2 diabetes.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) says that Type 2 diabetes usually begins with insulin resistance or the inability of the fat, muscle and liver cells to use the insulin produced in the pancreas to carry sugar into the body’s cells to use for energy. At first, the pancreas will work harder to make extra insulin, but eventually it won’t be able to keep making enough to maintain normal blood glucose levels, and glucose will build up in the blood instead of nourishing the cells. That’s when diabetes Type 2 has developed and needs to be treated.

In the United States, according to the Centers for Disease Control, 29.1 million people — 9.3 percent of the population — have diabetes. About 95 percent of those people have Type 2 diabetes, a disease that can be prevented, reversed and maybe even cured.

“While lifestyle factors of obesity, poor diet and exercise are risk factors for Type 2 diabetes, a genetic component frequently predisposes an individual to the disease,” says Dr. Ronald Tamler, medical director of the Mount Sinai Clinical Diabetes Institute in Manhattan.

Dr. George King, chief scientific officer at Joslin Diabetes Center in Boston, says he hesitates to use the word “cure” but, with the proper diet and exercise, a person with Type 2 diabetes can go into remission for decades without treatment. King says that while we know that obesity and being overweight are major causes of the disease, only about 20 percent of people who are overweight and obese develop diabetes. “Something is preventing the majority of overweight and obese people from developing Type 2 diabetes, and when we find out what that is, that’s when we will likely be able to find a cure,” King says.

Experts agree that the best time to reverse or prevent the onset of Type 2 diabetes is when a person is prediabetic, when blood glucose levels are higher than normal but not high enough to be diagnosed as diabetes. A person who has pre-diabetes is not only at increased risk for heart disease and stroke, but for developing Type 2 diabetes within 10 years.

Dr. Brandon Colby, a prominent California physician who practices personalized age management medicine, says pre-diabetes can initially show no symptoms or can cause dizziness and fatigue. As a person gets closer to a Type 2 diabetes diagnosis, he says, numbness and tingling or the feeling of pins and needles in the fingers and toes may begin, a sign that the body is having trouble processing sugar.

“Physicians normally don’t pay attention to pre-diabetes,” Colby says, “but patients should insist they be tested for it, so that they can begin to reverse it by changing diet, increasing exercise and being warned about complications of the disease.”

The Diabetes Prevention Program, a seminal National Institutes of Health research study, was a research initiative that worked with overweight participants whose blood sugar levels were higher than normal but not high enough to be diagnosed as Type 2 diabetes and who had risk factors for diabetes. The study showed that weight loss and exercise for people at risk of Type 2 diabetes significantly prevents or delays the onset of disease, as does the drug metformin.

Dr. Aaron Cypess, clinical investigator at the NIDDK, says the study showed that weight loss and exercise for people at risk of diabetes Type 2 significantly prevent or delay the onset of disease, as does the drug metformin. A 10-year follow-up showed that prevention or delay of diabetes was most persistent in the lifestyle group.

Cypess says the study indicates that early stage Type 2 diabetes can be reversed and that early stage prevention is also effective. “When blood sugar is still close to normal, no pills are being taken and no insulin or other drugs are being used, a reversal has taken place, but the longer one has had diabetes, the less likely it is that it can be reversed,” he adds.

Dr. Philip Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute and professor of surgery at the clinic’s Lerner College of Medicine, defines remission as five years with normal blood sugar and no medication. He says the only treatment that has been able to meet the American Diabetes Association (ADA) definition of cure, published in the American Diabetes Association journal Diabetes Care, is bariatric surgery.

When Katy Wiley learned about Schauer’s pending diabetes Type 2 research trial, she took a chance that she might qualify. Once the initial testing to determine her eligibility was completed, she was assigned to the gastric bypass therapy group. The other groups included one in which patients received intensive medical therapy only, including medication and counseling, and one that received sleeve gastrectomy, a different bariatric surgery procedure.

The trial, STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently), found bariatric surgery to be the most effective in reversing Type 2 diabetes.

“At the five-year follow-up, a significant percentage of bariatric surgery patients had met the ADA’s definition of cure,” Schauer says.

In June, Diabetes Care devoted an entire issue to the guidelines for eligibility for the bariatric surgery. Schauer says it’s important to understand, though, that the first recommendation for Type 2 diabetes treatment is exercise and diet, followed by the addition of insulin and other drugs.

“Only after lifestyle intervention and medical therapy have been proven to be unsuccessful, is surgery recommended,”Schauer says. “And the risks of complications or death are low — about as safe as the risks for procedures like gallbladder surgery and hysterectomy.”

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