Clinical trials available for people with diabetes.
For Christa Wolfe, diabetes runs in her family. She seemed to be following in her parents’ footsteps when she developed diabetes in her mid 50s. Her mother and father had been diagnosed with diabetes at the same age.
Christa is a native of Germany who moved to Pennsylvania with her American husband in the 1990s. The couple later retired to Florida, where Christa enjoys water aerobics and bicycling.
Now age 71, she praises Meridien Research for keeping her aware of how to stay healthy with diabetes.
Christa has Type 2 diabetes. It is the kind of diabetes that typically arises in adulthood but is also now occurring in teens and children. A healthy diet and exercise are an important part of managing Type 2 diabetes, and many with the disorder will need medication.
Christa has participated in two clinical trials for diabetes medication at the Bradenton facility of Meridien Research, an independent medical research clinic with six locations throughout central Florida.
She recently completed a trial that tested the injection-pen delivery of a medication for diabetes. An outcome for Christa was improved blood sugar levels.
“My blood sugar levels are fantastic for the first time in years,” she shares. “I’m totally thrilled about my numbers.”
However, Christa says, she receives a large benefit overall through participating in diabetes studies at Meridien Research. The facility’s medical staff has taught her how to better manage her diabetes, and she feels that her health has been carefully monitored with nothing overlooked.
At every visit, she sees Louis B. Chaykin, MD, a board-eligible endocrinologist and principal investigator who leads diabetes studies at Meridien Research.
“I like the whole group, and I really love Dr. Chaykin,” she says. “From day one, Dr. Chaykin and the staff have helped me learn about how diet affects diabetes, and exercise, too. Everything is checked through all kinds of tests, like for my heart, which I appreciate.”
Specialty Care Access
Meridien Research runs clinical trials on many conditions such as Alzheimer’s disease, high cholesterol, gout and various gastrointestinal disorders, plus issues regarding migraine, eczema and more.
People who are interested in participating can learn more about qualifications and which trials are being offered currently by visiting www.meridienresearch.net.
A number of studies for diabetes medications have taken place or are ongoing at the research company’s Bradenton location.
Finding new medications and methods for treatment is imperative to help people caught in the diabetes epidemic occurring all over the globe, says Dr. Chaykin. The disease can be debilitating when uncontrolled, leading to complications such as blindness, kidney failure, heart disease, poor wound healing that results in amputations, and more.
“We have an epidemic of diabetes not only in our country but in the world,” he notes. “For example, the number of Americans who have been diagnosed with diabetes has doubled to over thirty million in the past fifteen years. Worldwide, the estimate is that three hundred seventy-five million people have diabetes. So it’s a huge problem.”
At Meridien Research, Dr. Chaykin has overseen between 40 and 50 clinical trials to research medications for diabetes or diabetes complications. They have included assessing how they control blood sugar levels, and various methods of medication delivery.
They have also included clinical trials for how diabetes medications affect the heart, which the Food and Drug Administration now requires for all new diabetes medications.
A clinical trial is a research study that investigates whether a medical approach, treatment or device is effective and safe for use with people. At Meridien Research, qualifications for enrollment vary with each study and include factors ranging from age to medical history. Medical insurance isn’t required, and eligible participants receive study-related care, monitoring and medication at no cost.
In diabetes studies, diet and lifestyle counseling are part of the care. In general, people who participate in the studies don’t usually have ideal control of their disease, says Dr. Chaykin, and education can help.
“People with diabetes can come to Meridien Research and be educated about their disease and its complications while taking part in the latest therapies or combination of therapies to improve their quality of life,” he notes. “Throughout the clinical trial, they are seen regularly not only by the coordinator but also by me at every visit.
“In some trials, I have the flexibility to add medications to improve their diabetes. A lot of patients in cardiovascular outcome trials, for example, have done extremely well in improving blood sugar control because they spent time with us getting laboratory studies, electrocardiograms, physical exams and adjustments in medications.”
Many diabetic patients at Meridien Research are under the care of an endocrinologist for the first time through Dr. Chaykin. An endocrinologist specializes in treating hormonal disorders like diabetes, but access is often limited.
“There are a small number of endocrinologists across the country, and only about three to four percent of people with diabetes are able to see a specialist,” he says. “People may not have insurance, or have limited insurance, which can keep them from seeing a specialist.”
An extensive physical examination is part of being in a diabetes clinical study at Meridien Research. It can provide peace of mind that any signs of diabetic complications will be detected. For instance, eyes are checked for diabetic-related visual complications, and patients receive neurological exams and a complete battery of laboratory tests.
The quality of patient care at Meridien Research impressed Christa.
“The whole staff, in my opinion, is very good,” she attests. “They’re very efficient – I’ve never had to wait after I arrive for my appointment.
“Dr. Chaykin is calm and friendly. He always gets to the point about what is happening and is very clear.”
Christa experienced the benefits of joining a research study at Meridien Research: She was able to play an active role in her health care and obtained care from a specially trained medical staff.
She first started as a participant in a Meridien Research study ten years ago, when she enrolled in a clinical trial that involved medication for hot flashes. Christa later enrolled in a study that examined a diabetes complication. In a third clinical trial, she helped test how a medication is delivered.
Christa feels confident she will stay in good health with diabetes due to the education she received during the trial. She eats healthy and gets exercise by riding her bicycle every day. In addition, the medication she received through the trial helped bring her blood sugar down. She is elated that she found Meridien Research, Dr. Chaykin and its staff. The effect on her diabetes has been positive.
“I’m absolutely thrilled with the care I’ve received,” she says.