Lifestyle intervention has modest impact on glycemic control in type 2 diabetes
medwireNews: Adding an intensive lifestyle intervention to usual care slightly improves glycemic control but substantially reduces the need for glucose-lowering medication among patients with non–insulin-dependent type 2 diabetes, suggest trial results published as a preliminary communication in JAMA.
Mean glycated hemoglobin (HbA1c) levels decreased by 0.31% from a baseline of 6.65% among the 64 participants randomly assigned to receive the 12-month lifestyle intervention in addition to usual care, whereas the 34 patients receiving standard care alone experienced a decrease of 0.04% from a baseline of 6.74%, giving a nonsignificant between-group difference of –0.26%.
The 95% confidence intervals around this difference, at −0.52% to −0.01%, were not contained within the equivalence margin of ±0.4%, meaning that the “intensive lifestyle intervention was nonequivalent compared with standard care in relation to maintaining glycemic control, with the modest reduction in HbA1c favoring the lifestyle group,” say Mathias Ried-Larsen (University of Copenhagen, Denmark) and study co-authors.
And the researchers observed a “substantial” reduction in the use of glucose-lowering medication from baseline to month 12 among participants receiving the lifestyle intervention versus standard care only, with 73.5% versus 26.4% of patients reducing their medication use.
And post hoc analyses showed that a higher proportion of patients in the lifestyle versus standard care group stopped using glucose-lowering medication (56.3 vs 14.7%), whereas fewer patients in the lifestyle group increased their medication use over the study period (10.9 vs 44.1%).
The lifestyle intervention involved five to six weekly aerobic sessions, of which two to three included resistance training, in addition to dietary planning aiming for a body mass index of 25 kg/m2 or less. All participants received usual care, consisting of medical counseling, education in type 2 diabetes, and lifestyle advice, in addition to standard treat-to-target medical therapy.
Musculoskeletal pain or discomfort was the most commonly reported adverse event, experienced by 21.9% of participants receiving the lifestyle intervention and none of those in the usual care group. Mild hypoglycemia, gastrointestinal problems, and mild hypotension occurred in a corresponding 12.5% versus 0%, 6.3% versus 9.0%, and 6.3% versus 0% of patients.
This excess of adverse events in the lifestyle intervention group “may be ascribed to higher susceptibility in this group in relation to, for example, mild hypoglycemia because of the combination of lifestyle and medical therapy,” suggest the study authors.
Ried-Larsen and colleagues caution that only participants with type 2 diabetes diagnosed within the past 10 years were included in the trial, which “may limit generalizability” of the findings.
“Prolonged diabetes duration, poor glycemic control, and insulin dependence may reflect a more progressive disease state,” they add.
And the team concludes that “[f]urther research is needed to assess superiority” of the lifestyle intervention over standard care, “as well as generalizability and durability of findings.”
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