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Volunteers with Type 2 diabetes are still needed for a continuing national study of the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating Type 2 diabetes.
The University of Alabama at Birmingham is one of 50 institutions across the nation participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, or GRADE study. GRADE is sponsored by the National Institutes of Health with a goal of enrolling 5,000 patients nationwide.
“The GRADE study is the first comparative effectiveness study which will look directly at the four major treatments for diabetes, compare them, and try to determine which one or ones are the best for treating Type 2 diabetes,” said Andrea L. Cherrington, M.D., associate professor of preventive medicine and co-primary investigator at UAB. “At present, there is little consensus on which combinations of the current diabetes drugs in conjunction with metformin will best serve different patient populations.”
Metformin is widely accepted as the first medication that should be used to treat Type 2 diabetes; however, most patients eventually require an additional medication to manage the disease. The results of GRADE will help doctors guide the management of individuals with Type 2 diabetes in the future and might provide more immediate benefits now to those who participate.
Phil Ferguson has been enrolled for more than a year. He knew his blood sugar levels had been rising over time, but he did not fully grasp the need to take control of his diabetes until he became involved in the study.
“The best part of this study has been the people conducting it,” Ferguson said. “They are informative and compassionate and really help you understand how diabetes affects you. I’m in a much better place now for having joined the GRADE study, and I’ll miss it when it wraps up in a few years.”
The GRADE study is looking to enroll a cross section of patients with Type 2 diabetes of any age, gender and ethnicity. The study will follow its participants for seven years and will provide free medications and diabetes care. Contact Dana Golson at 205-996-4015 or firstname.lastname@example.org for more information on enrolling in the study.
“It is estimated that nearly one in three children, and one in two minority children, born after the year 2000 will develop Type 2 diabetes,” said W. Timothy Garvey, M.D., professor and chair of the Department of Nutrition Sciences, director of the UAB Diabetes Research Center, and co-primary investigator at UAB. “Type 2 diabetes progresses gradually, and this study will help us understand how different combinations of medicines affect the disease and the people who are taking those medications over time.”
Type 2 diabetes is an epidemic that threatens to become the century’s major public health problem and poses enormous human and economic challenges worldwide. Nearly 26 million Americans are affected by diabetes, and 79 million have pre-diabetes.
GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
Earnest Tate is no stranger to adversity or history. When he was named the first black police chief of Selma in the late 1990s, he had to lead and unify a police force that had been heavily scrutinized during the civil rights era.
“My goal was to make it the best police department in the state of Alabama, and I did that,” Tate said.
Nearly 20 years later, Tate is now retired and works on his family farm in the city where he made history. But a minor heart attack that led to heart failure threatened his ability to work the land he loves so dearly.
“I tried to not show sickness; but since my wife was a nurse, she still saw it,” Tate said. “It made a big impact on my whole family. I never got scared because I never had time to get scared.”
Tate recalled that it was hard to breathe while standing up. He says it would take him a long time to walk from the bedroom to the kitchen.
After consulting with his primary care physician in Selma, Tate was sent to UAB for a consultation. It was there that he met James Davies, M.D., and Oluseun Alli, M.D., and learned he had a condition called aortic stenosis.
Aortic stenosis occurs when the heart’s aortic valve narrows, preventing the valve from opening fully.
Mark F. Sasse, M.D., an associate professor of interventional cardiology, says Tate’s heart pumping function was significantly reduced compared to normal.
“The pumping function of Mr. Tate’s heart was fairly reduced, so he was at a higher risk than our normal transcatheter patients,” Sasse said. “The percentage of blood being pumped out was nearly 30 percent less than in people with normal pumping function.”
The structural heart team of Davies, Alli and Sasse determined that Tate was a prime candidate for transcatheter aortic valve replacement.
Sasse says transcatheter aortic valve replacement, or TAVR, provides easier recovery compared to open-heart surgery as patients typically do not stay in intensive care as long.
In the TAVR procedure, a replacement valve is placed inside a catheter. The catheter is then threaded through blood vessels in the leg or through the chest of the patient. The valve is then positioned into the old valve while the heart is still beating. The heart is able to pump blood through the replacement valve normally.
After the TAVR device was successfully placed, Tate said he felt physically better soon after the procedure was complete. Sasse is happy to see that his patient is doing well and ready to get back to a normal life.
“We took a person who was very debilitated and gave him back his life,” Sasse said. “He couldn’t sleep at night. Now he can sleep. People who can’t do daily activities are able to do those things now. That’s the real benefit of this procedure.”
After visiting with Sasse for a one-month checkup, Tate is now feeling better and is able to do the things he wants to do without feeling tired.
“I can rest better at night,” Tate said. “I used to be too tired to eat. My appetite came back. I used to have to ride in a wheelchair, but I don’t have to ride in a wheelchair anymore.”
|UAB was the first hospital in the state of Alabama to perform the TAVR procedure, in 2012. More than 300 total cases have been completed since then.|
UAB was the first hospital in the state of Alabama to perform the TAVR procedure, in 2012. More than 300 total cases have been completed since then. Sasse says his staff averages four or five per week.
“With people who had been considered for open-heart surgery in the past, we’ve noticed certain subgroups, typically the elderly, don’t do well,” Sasse said. “All these patients were offered high-risk surgeries or nothing at all. TAVR gave them another option.”
The sky is the limit for people with heart failure, according to Sasse. UAB is already in its third iteration of the valve with the Sapien-3 valve.
“The engineering keeps getting better each time,” he said. “The companies are still working on making them better. The future is bright for treating a bigger patient population.”
That is good news for patients like Tate. Now 80 years old, Tate is back happily calling his cows and tending to his farm, and feels he has plenty ahead of him.
“It was a relief to go home,” Tate said. “It took me several months to get sick, and I know it is going to take several months to get well. I believe now I can live to get 100 years old. It’s what I feel.”
The Women’s Committee of the Spain Rehabilitation Center will host its signature benefit and Valentine’s Day celebration, “The Firefly,” on Saturday, Feb. 13, at The Florentine at 6 p.m.
This year, the committee will honor former patients Kelly Garner and Ryan Robinett.
Garner is an author, inspirational speaker and community leader. Following a near-death experience and extraordinary recovery, he wrote the book “The Night That Changed Our Lives.” Garner’s book was inspired primarily by his experience during the massive January 2014 snowstorm in Birmingham.
Garner became familiar to many in the Birmingham area as the Good Samaritan during the storm when he offered assistance to stranded motorists and was injured after falling 40 feet off a cliff into a ravine. He spent over 12 hours in single-digit temperatures before a neighborhood rescue party located him early the next morning. He survived the fall but suffered shattered vertebrae and fell into a severe diabetic hypoglycemic state. Some doubted he would ever walk again; but after numerous surgeries and rigorous rehabilitation at the Spain Rehabilitation Center, he has beaten the odds. Just a year after this incident, he completed the Mercedes half marathon. His surgical team was so inspired by his story that they ran the race with him.
A native of Birmingham, Robinett serves as the managing director of Computer Technology Solutions’ Birmingham Operations. Ryan received his MBA from the UAB.
Robinett was introduced to Spain’s Research and Rehabilitation programs in 2014 after experiencing a sudden onset of neurologic issues. Over the course of 16 months, his ability to walk deteriorated significantly. He has since made a full recovery following intense physical rehabilitation at Spain, is medicine-free and has been granted full medical release.
Throughout his medical trials, Robinett has been an advocate and partner of UAB research, especially focusing on demyelinating diseases. He is an advocate of innovative ways to improve current rehabilitation methods, particularly involving neuro-physical rehabilitation.
To make a donation, please contact Catherine Newhouse.