This article first appeared in the St. Louis Beacon, May 9, 2012 - Frequent exercise, good nutrition and often a single medication have turned out to be an ideal regimen for helping many adults control their type 2 diabetes. But what works for adults has turned out to be less effective in children, according to results of the first major national study of treatment options for type 2 diabetes among young people.
The ongoing study sponsored by the National Institutes of Health involves 699 youngsters, including about 60 from the St. Louis area. Heading the local research is Dr. Neil H. White, professor of pediatrics and director of the Pediatric Clinical Research Unit at Washington University School of Medicine.
For nearly eight years, White and other local researchers have been tracking youngsters between the ages of 10 and 17 to test the impact of three approaches to controlling their blood sugar. Each patient followed one of three protocols:
- treat with only metformin, a drug that controls blood sugar levels;
- treat with metformin and rosiglitazone, a drug that is an insulin sensitizer;
- or treat with metformin and lifestyle changes, such as exercising and better nutrition.
The researchers didn't expect the findings of the study. Combining metformin with lifestyle intervention was no more helpful than using metformin alone. The conventional wisdom has been that more physical activity and other lifestyle changes will make a difference in health, but that hasn't been the outcome for most youngsters in the study.
"That was a surprise," White says of the results relating to lifestyle changes. He says the failure rate was 46.6 percent for those seeking to control blood sugar through a combination of meformin and lifestyle intervention; 51.7 percent for the medformin-only group, and 38.6 percent for the metformin and rosiglitazone group.
The findings, reported recently in the New England Journal of Medicine, suggest that two drugs might be more effective than one in treating type 2 diabetes among youngsters. But which two? So far, White notes that metformn and insulin are the only two drugs the Food and Drug Administration has approved for treatment for type 2 diabetes in children.
For now, he says, "we should be very aggressive in treating the children with metformin plus insulin. We should be very aggressive in testing other medications for diabetes for children."
The youngsters in the study were far from average. To participate, they had to have had type 2 diabetes for less than two years and have a body mass index in the 85th percentile, meaning that based on sex, age and height, they had to be heavier than 85 percent of youngsters of the population.
"Many of these kids were very, very overweight," White said. "We had young teenagers weighing 300 plus pounds."
He wouldn't speculate on the cause of the growing presence of diabetes among young people, first noticed during the 1990s. But he says the chronic condition "has tracked very closely with the increasing rate of obesity in children."
He says some of the patients are now in their early 20s, and that continuing to follow them will provide more understanding of the long-term consequences of diabetes and its complications, such as heart disease. The National Diabetes Information Clearinghouse reports that from 2002-05, 3,600 youth were newly diagnosed with type 2 diabetes each year.
In addition to the health consequences, many point to the economic impact of out-of-control diabetes. In 2007, direct and indirect costs of the disease were put at $174 billion. The Clearinghouse added that medical expenses for people with diabetes were more than two times higher than for people without the disease.
While some might view the results of the national study with a sense of hopelessness, White said the findings mean "we've learned a lot about this disease in children and it will enable us to develop and study new methods and techniques for doing better for them."
He added that "We can't just leave them. We can't just treat them as if they are only a little bit sick. We have to treat them as if they really need our help very aggressively and very early. Hopefully, that will have an impact on their future health and life."
White didn't know why lifestyle interventions, which is known to help adult diabetics, didn't have much of an impact on children.
"In this particular population, it did not have a very good impact. That was not our expection when we started the study. We cannot say at this point whether or not the subjects didn't participate aggressively enough in that therapy or whether it doesn't work. But it did not appear to help them control their blood sugar."
The lifestyle intervention part of the study required a parent or another family support member to meet with health professionals to be taught about weight loss through diet, exercise and other healthy behaviors. The health professional met with the family supporter at least every week or two for six months, then communicated by telephone during the next six months.
White said,"we actually don't have a good way of knowing what they (family support member) actually did because they did it on their own. All we can tell is what we taught them to do and reinforced what they should do and what they reported to us."
He said some data on that part of the study had yet to be analyzed and may be reported later.
One unanswered question, he added, is whether more aggressive lifestyle intervention and weight loss might be more beneficial and successful in preventing the onset of diabetes among the young.
"In the adult population, it has been shown that weight loss affects the development of diabetes, and I think that is probably going to be true in this group as well. But that has not been studied. However, once they get diabetes, we learn that it's a lot more difficult to treat them than we had thought. So we have to be very aggressive."
