GRADE study evaluates four new medications for Type 2 diabetes

The GRADE study at the University of Alabama at Birmingham had a special visitor in November. Red suit. Black boots. White beard. Belly that shook like a bowl full of jelly. A V.I.E. (Very Important Elf) visited this national clinical trial for Type 2 diabetes.

The GRADE study is evaluating four new medications for Type 2 diabetes. Patient confidentiality issues prohibit UAB from confirming anything about the health status of any patient, including our V.I.E. Suffice it to say that the Big Guy has some risk factors for diabetes.

"He has several risk factors associated with the development of Type 2 diabetes," said Andrea Cherrington, M.D., associate professor of Preventive Medicine in the School of Medicine. "He's overweight, he has a pretty sedentary lifestyle, and he doesn't maintain the healthiest diet. These risk factors are also related to the development of cardiovascular disease, high blood pressure and stroke."

The GRADE study is a large, multisite research effort sponsored by the National Institutes of Health. The primary investigators for the UAB component of the study are Cherrington and W. Timothy Garvey, M.D., professor and chair of the School of Health Professions Department of Nutrition Sciences and director of the UAB Diabetes Research Center.

GRADE is comparing four medications currently being used to treat Type 2 diabetes to be taken in conjunction with metformin, the most established medication used in the majority of diabetes cases.

As the disease progresses, many patients taking metformin eventually require an additional medication to control blood sugar. At present, there is little consensus on which combinations of the current diabetes drugs in conjunction with metformin will best serve different patient populations.

"It's a bit of a guessing game for physicians right now, as we really don't have any good scientific evidence to help guide the decision-making about which combination will be the best regimen for each individual," Cherrington said.

The GRADE study is looking to enroll a cross section of patients with Type 2 diabetes: any age, any gender, any 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 [email protected] for more information on enrolling in the study.

As far as the guy in the red suit is concerned, Cherrington says he needs to be thinking about some lifestyle modification.

"He's overweight, his assistants do most of the physical activity at the workshop, and he's flying around, not walking," said Cherrington. "And then there is the dietary component. Frequent sweets, cookies, high-fat milk — that's pretty much the opposite of what we would recommend for good diabetes prevention or management."

Cherrington suggests he needs to hop out of the sleigh every so often and walk more, and she recommends that families replace the cookies with fruits and vegetables, and leave a bottle of water out to help him stay hydrated on his Christmas Eve travels. Those same recommendations hold true for anyone who is at risk for diabetes.

"The great news is that we know that people with Type 2 diabetes who maintain their blood sugar within range and make these behavioral changes find it possible to live long, healthy lives," Cherrington said. "The key points to diabetes management right now are lifestyle modification: Maintain a healthy weight; include whole grains, fresh fruits and vegetables as part of a healthy diet low in saturated fats; and stay physically active to the best of your ability."

Cherrington says this time of year can be especially troublesome for people with diabetes.

"There is a lot of stress related to the holidays, and we know that stress can exacerbate Type 2 diabetes," she said. "Approach the holidays with a plan. Find ways to be physically active. Eat something healthy before going to a party, and pick healthy options whenever possible while there. You can enjoy yourself at a holiday gathering and enjoy the tasty treats of the season; but try to do it in a careful, planned manner."

Mr. C seemed to take the recommendations to heart as he left the UAB clinic. For laying his finger aside of his nose and giving a nod, down the hallway he strode. But we heard him exclaim, as he walked out of sight, "I want to be around quite a bit longer. I have children to delight."