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Groundbreaking NIH Diabetes Study Helps Patients Make the GRADE


Maria Gaona has been battling diabetes for eight years. Coupled with a family history of the disease, poor eating habits and no exercise regimen, the 64-year-old faces a lifetime of daily medications to control her disease. Fortunately, in 2014, she enrolled in a groundbreaking national research study that has already helped her control her glucose level, lose 16 pounds and regulate her daily medications. Researchers predict her participation in the seven-year trial will help develop treatment guidelines that could help millions of diabetic patients in the future.

“I knew I had to make changes,” Gaona says. “And with regular visits with the research staff and my doctors, I’ve been able to change my eating habits that have helped my health.”

Harris Health System and researchers from Baylor College of Medicine are looking to enroll many more Type 2 diabetes patients like Gaona (patients who have been diagnosed within the last 10 years and are only taking metformin, the most common first-line diabetes medication prescribed) to participate in one of the nation’s largest and most comprehensive studies ever conducted by the National Institutes of Health.

The major goal of the study is to identify how patients on metformin respond when their medication is coupled with one of four other diabetes drugs. Participants are randomly assigned one of the four drugs. For patients who meet the entry criteria, all diabetes medicines, study tests and visits with the study physicians are provided free of charge.

“This is a critically important study to determine the most effective, as well as the most cost-effective, combination of drugs needed to achieve long-term control in patients with Type 2 diabetes,” says Dr. Ashok Balasubramanyam, chief, Endocrine Service, Harris Health Ben Taub Hospital, and principal investigator, Baylor College of Medicine. “What we learn from this study will have a great impact on diabetes treatment for many years to come.”

The study compares the effects of the drug combinations on glucose levels, adverse effects, diabetes complications, cost and quality of life for patients. Glycemic Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study is one of the longest and most comprehensive diabetes trials undertaken by NIH. In all, 42 sites across the country are participating—Houston is one of three sites in Texas.

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, according to NIH.

Dr. Erica Gonzalez, study coordinator, Baylor College of Medicine, underscores the importance of the research and the need for more ethnic minority group participation because of its far reaching implications.

“It’s important for us to communicate that properly designed and conducted research studies like GRADE are important and helpful to patients, especially among African Americans and Hispanics.  Patients belonging to these ethnic minorities may be hesitant to enroll or have a misunderstanding of what their participation entails,” she says. “By not enrolling, they’re missing out on cutting-edge treatments and care. We want to educate all patients with Type 2 diabetes in Houston, and have them take advantage of the study opportunities.”

Gaona, a patient at Harris Health’s Gulfgate Health Center, agrees and encourages other Hispanic and African Americans to learn more about the research and not pass on an opportunity to better their health.

“They should know it’s not bad or difficult to participate,” she says. “Don’t let your health suffer because you don’t take time to find out about the research or ask questions.”

For more information or to participate in the GRADE study, call 713-798-3625 or visit