ORLANDO — A behavioral lifestyle intervention focused on diet and exercise in obese individuals with type 2 diabetes resulted in an impressive reduction in elevated high-sensitivity C-reactive protein levels at 1 year in the Look AHEAD investigation.
“The magnitude of reduction in CRP was similar to that seen in statin trials, particularly JUPITER,” Dr. Maria Belalcazar noted at the annual scientific sessions of the American Heart Association.
That's an encouraging parallel in light of the spectacular success of JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), which was halted for ethical reasons after a median 1.9 years of follow-up because of a significant reduction in cardiovascular events in statin-treated nondiabetic subjects with increased systemic inflammation as reflected by an elevated baseline CRP, said Dr. Belalcazar of the University of Texas Medical Branch at Galveston.
The intervention utilized in the Look AHEAD (Action for Health in Diabetes) study led to salutary changes in glycosylated hemoglobin, body weight, blood pressure, fitness, and need for antidiabetic medications.
Of note, the investigators found that only the changes in glycosylated hemoglobin, body mass index, and waist circumference independently predicted a reduction in CRP level in multivariate regression analyses.
“Improvements in glucose control achieved with the intensive lifestyle intervention in Look AHEAD were associated with a decrease in CRP levels independently of changes in weight, fitness, and lipid control. This suggests that the modality with which glucose is lowered is important when considering its effect on CRP,” Dr. Belalcazar said.
Look AHEAD is a 16-center U.S. study involving 5,145 overweight or obese adults with type 2 diabetes. They were randomized to the intensive lifestyle intervention or usual-care diabetes education and support.
All subjects continued to see their primary care physicians.
The 1-year impact on traditional cardiovascular risk factors has previously been reported (Diabetes Care 2007;30:1374–83).
Dr. Belalcazar reported on the 1,759 participants for whom baseline and 1-year CRP measurements were available. The investigators decided to take a closer look (see box) at this subgroup in light of the JUPITER results.
The weight loss intervention included three group sessions and a single one-on-one session per month with psychologists, dieticians, and exercise specialists during the first 6 months, and one fewer group session per month in months 7–12.
Caloric restriction through the use of liquid meal replacements and frozen entrees provided free of charge was the main weight loss tool used by the study participants.
The home-based physical activity program encouraged a build-up to a target of 175 minutes of moderate-intensity exercise per week, with walking encouraged.
The central question is whether the reduction in CRP and other benefits on surrogate markers of cardiovascular risk achieved nonpharmacologically through the Look AHEAD lifestyle intervention will translate into a significant decrease in cardiovascular event rates during ongoing follow-up planned for up to another 8 years.
The Look AHEAD investigation is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases.
Dr. Belalcazar reported no financial conflicts.
Source Elsevier Global Medical News