• Prevention & Screening
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials
• Cardiometabolic Disorder
• Obesity

For overweight patients with type 2 diabetes mellitus (T2DM), a program of intensive lifestyle intervention is more effective in promoting weight loss, improving glycemic control, and reducing cardiovascular (CV) risk factors than standard diabetes education, according to 4-year results from the Look AHEAD: Action For Health in Diabetes trial (NCT00017953).

Look AHEAD is the first prospective trial to evaluate the long-term effects of intentional weight loss on CV outcomes in patients with T2DM. Donna H. Ryan, MD, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA, presented 4-year results from the Look AHEAD trial.

The Look AHEAD trial randomly assigned 5145 overweight patients with T2DM to treatment programs that included diabetes support and education (DSE) and intensive lifestyle intervention (ILI). Patients in the DSE group (n=2575) attended education sessions 3 to 4 times per year on diabetes management, nutrition, and exercise. Patients in the ILI group (n=2570) attended weekly group sessions for 6 months that focused on developing the behavioral skills that are necessary for weight loss, followed by biweekly sessions for an additional 6 months that focused on how to maintain weight loss. The weight maintenance group sessions continued on a monthly basis for an additional 3 years. The primary composite endpoint of the Look AHEAD trial was time to first CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina.

Mean body mass index (BMI) was 35.9 mg/k² in the ILI group and 36.0 mg/k² in the DSE group at baseline. Patients in the ILI group lost 8.6% of their body weight after the first year of the program and sustained a weight loss of 4.7% through Year 4. By comparison, those in the DSE group lost a significantly smaller percentage of body weight in the first year (0.7%; p<0.0001) and after 4 years (1.1%; p<0.0001).

At 4 years, the ILI program provided greater improvements in fitness, glycemic control, and CV risk factors, such as blood pressure (BP) and high-density lipoprotein (HDL), than the DSE intervention. Compared with DSE-managed patients, patients in the ILI group had a:

• Higher increase in fitness level: 5.4% vs −0.8%

• Greater change in HbA1C level: −0.20% vs −0.08% (p=0.001)

• Greater likelihood of achieving target HbA1C of <7.0%: 57% vs 51% (p<0.0001)

• Greater improvement in systolic BP: −4.66 mm Hg vs −3.41 mm Hg (p=0.01)

• Greater increase in HDL: 3.95 mg/dL vs 2.58 mg/dL (p<0.0001)

Reflecting greater improvements in glycemic control, patients in the ILI group were less likely than those in the DSE group to use diabetes drugs and insulin throughout the 4-year follow-up period (Table 1).

The majority of patients in the ILI and DSE groups achieved target BP levels of <130/80 mm Hg (63% vs 60%; p=0.08). Patients in the ILI and DSE groups also had similar improvements in triglyceride levels (−22.90 vs −27.51 mg/dL; p=0.13) and, after controlling for statin use, similar improvements in low-density lipoprotein (LDL) levels (−12.71 vs −13.78 mg/dL; p=0.19). However, patients in the DSE group were more likely than those in the ILI group to achieve an LDL target of <100 mg/dL (64% vs 61%; p=0.02).

Future follow-up analyses will focus on the effects of intentional weight loss on CV events, Dr. Ryan said.

• © 2011 MD Conference Express