Joining a Clinical Trial
What it’s really like to participate in a research study
Research centers evoke ideas of bright lights and sterile environments, which can intimidate someone considering enrollment in a clinical trial. But two participants involved in different diabetes studies say the researchers they deal with are warm and always available to answer questions.
Julie Ozouf, who has type 2 diabetes and is currently enrolled in a National Institutes of Health (NIH) trial looking at leptin, a satiety hormone that plays a role in appetite, and lipodystrophy syndrome, a condition characterized by total or partial loss of fat cells. People with the disease lack leptin, often leading to abnormal blood lipid (cholesterol) levels and insulin resistance. As part of the trial, Ozouf has been injecting leptin twice a day for six months in the hopes that it will help control her blood glucose.
She had always wanted to aid medical science and thought this particular trial might also benefit her. “It is something that might help my out-of-control diabetes,” she says, “which is a big thing.”
She first heard about the trial during a nondiabetes-related trip to Georgetown Hospital in Washington, District of Columbia. An endocrinology fellow there was associated with the NIH and asked if Ozouf would be willing to participate. When she agreed to consider enrolling in the research trial, the team e-mailed her the informed consent document, which outlined everything about the trial, including potential risks. This gave her time to make a preliminary decision. “I had time to go over it and read it,” she says. “So I had an idea of what I was going to do.”
The decision to take three weeks off work for a hospital stay was tough, says Ozouf, who is a social worker in private practice. But she has a spouse who supports her, which helped her take the plunge.
When Ozouf arrived at the hospital, one of the lead researchers sat down with her and went through the informed consent document line by line so everything was very clear. Both the informed consent document and researcher emphasized that everything was voluntary and that Ozouf could stop at any time without retribution.
As part of the trial, Ozouf had to stay in the hospital for three weeks to undergo testing and observation. She had scans, screenings, and tests done, including a liver biopsy—all free of cost. Getting feedback from those tests was a real benefit: One of her CT scans was abnormal, which alerted her to follow up with her cardiologist. “I can’t tell you how valuable that is,” Ozouf says. “You hear how [the test] came out, if there are any problems, and they will provide treatment or refer you.”
A large portion of her hospital stay involved following a very specific diet. Ozouf’s biggest fear was that she wouldn’t get enough to eat, which turned out to be unfounded. She says she was full the entire time she was at the hospital.
During the first night of her three-week stay in the hospital’s metabolic unit, which is dedicated to patients enrolled in research studies, Ozouf says she had an emotional meltdown. “When you realize you’ve committed to three weeks, that’s a bit of a shock,” she says. “So, I had a big breakdown, and I called my husband and said, ‘I don’t know if I can do this.’ ”
When she spoke to the researchers about her feelings the next day, they were very understanding and were able to calm her. They even told her that her reaction was pretty common. Once over that hump, Ozouf says the stay was pretty easy.
“The first and third week you are incredibly busy with testing,” she says, “but the second week you have a little more downtime.” Despite that, she was never laying around in a hospital bed. Most days involved some kind of test, including an MRI or echocardiogram. There was Internet access, and she could have visitors in the evening.
The team was very patient and responsive to questions throughout her stay, which she says surprised her. “It felt like there was a lot of support while I was here, and I didn’t quite expect that,” Ozouf says.
Ozouf continues to take the leptin and follows her normal diet in daily life, and she says she will find out soon if it is actually helping to control her diabetes. Her continuation with leptin, however, is up in the air. The FDA approved leptin for the treatment of generalized lypodystrophy due to results from the trial, but not partial, which is what Ozouf has. Because they received approval, the researchers are done with the trial. But if the leptin is shown to help Ozouf, she may be able to move on to another study, where the medication will still be provided.
“I feel really grateful to be in the research and have the opportunity to try a drug,” she says. “But if it doesn’t [help], I’m glad I could help other diabetics with a drug that might be beneficial to them.”
D for Two
Michael Bloukas, who is currently enrolled in D2d, a trial looking at whether vitamin D supplementation can safely delay the onset of type 2 diabetes, agrees that the experience has been positive. “I was pleasantly surprised by the research that is done and the people in the program, he says. “So far it has been a very good experience, and I appreciate the people that I deal with.”
Bloukas was diagnosed with prediabetes in 2010 and was told by his primary care doctor that he needed to take measures to reduce his risk for type 2 diabetes. He lost a considerable amount of weight, studied up on diabetes, and changed his lifestyle, which improved his elevated blood glucose levels.
Bloukas’s doctor took notice of the progress and suggested he join the D2d trial. He didn’t have to think too hard about enrolling. “I thought it was pretty much safe,” he says. “It’s the study of vitamin D and its relationship to the disease, so even if I’m taking vitamin D rather than placebo, I don’t see a great deal of risk.”
Bloukas’s routine hasn’t changed much since enrolling in the trial. He still continues with his previous lifestyle changes, eats the same foods, and exercises, but now he takes a pill—Bloukas will have to wait to find out whether it’s a vitamin D supplement or placebo—every morning. He heads to the hospital every three to six months for a short or long visit, but it’s only two blocks from his office so he can fit a quick visit in on his lunch break.
During a short visit, he meets with the lead researcher and a nurse to talk about how things are going. Longer visits can take three to four hours. They will give him a sugary beverage to drink and take blood samples to observe how long it takes for his blood glucose to return to a normal level.
Bloukas says he would encourage others to consider a clinical trial if they feel it is safe and they can get some kind of satisfaction from the experience. “Personally, I’m open-minded,” he says. “If I think I can contribute, I will do it.”
Curious about clinical trials?
Find recruiting clinical trials in your area by visiting ClinicalTrials.gov