Lifestyle Over and Above Drugs in Diabetes Study

The study was done to determine the extent to which intensive dietary intervention can influence glycemic control and risk factors for cardiovascular disease in patients with Type 2 diabetes who are hyperglycemic despite optimized drug treatment.

The study was a randomized controlled trial with 93 participants aged less than 70 years with Type 2 diabetes and an A1c of more than 7% despite optimized drug treatments plus at least two of the following conditions; overweight or obesity, hypertension, and dyslipidemia.

The intervention was intensive individualized dietary advice (according to the nutritional recommendations of the European Association for the Study of Diabetes) for six months: both the intervention and control participants continued with their usual medical surveillance.

The main outcome measures were the A1c results and the secondary outcome measures included measures of adiposity, blood pressure, and lipid profile.

After adjustment for age, sex, and baseline measurements, the difference in A1c between the intervention and control groups at six months (-0.4%, 95% confidence interval -0.7% to -0.1%) was highly statistically significant (P=0.007).

After six months, levels of A1c in the intervention group declined from a mean of 8.9% to 8.4% but remained unchanged at 8.6% in the control group. Significant differences (favorable to the intervention group) were also observed in weight, body mass index, and waist circumference. Moreover, in 29% of the control group, prescribed doses of diabetes drugs were increased compared with 9% of the intervention group. However, doses of diabetes drugs were reduced in 13% of the intervention group compared with 4% of the control group. The main change in diet was a reduction in intake of saturated fatty acid by the intervention group (P = 0.006).

From the results it was concluded that intensive dietary advice has the potential to appreciably improve glycemic control and anthropometric measures in patients with Type 2 diabetes and unsatisfactory A1c results, despite optimized drug treatment.

Lifestyle modification is the recommended first-line therapy for glucose management and is supposed to be continued as treatment intensification almost invariably becomes necessary. Before the study by Coppell and associates, however, the benefits of intensive lifestyle intervention applied at later stages of diabetes therapy had not been investigated. Although relatively modest, the reduction in A1c levels (as well as weight and waist reductions) occurred after only six months of dietary changes. Of course, these benefits are notoriously short-lived. Whether further reductions would occur with ongoing intervention or the reductions could be maintained after cessation of the intervention remains to be seen. However, a recent study found that A1c levels remained lower among newly diagnosed patients who initially lost weight (compared with those who gained weight ) even after the weight was regained, and diabetes prevention studies have found long-term benefits in lifestyle modification well after the interventions ended. In light of these findings, the current study suggests that lifestyle modification may be beneficial regardless of when it is initiated.