Gert van der Hoek
In Memoriam - Editor, Senior Moderator
[FONT="]August [/FONT][FONT="]15, [/FONT][FONT="]2017[/FONT]
[FONT="]Key Points[/FONT]
[FONT="]Question Can an intensive lifestyle intervention achieve glycemic control comparable with standard care in patients with type 2 diabetes?[/FONT]
[FONT="]Findings In this randomized clinical trial of 98 adults with type 2 diabetes diagnosed for less than 10 years, and which was designed to assess equivalence, the lifestyle intervention vs standard care resulted in a mean change in hemoglobin A[SUB]1c[/SUB] level of −0.31% vs −0.04%, respectively. The 95% CI around the difference (−0.52% to −0.01%) exceeded the prespecified equivalence margin of ?0.4%.[/FONT]
[FONT="]Meaning An intensive lifestyle intervention did not meet the criterion for equivalence for glycemic control, but the direction of findings suggests potential benefit.[/FONT]
[FONT="]Abstract[/FONT]
[FONT="]Importance It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.[/FONT]
[FONT="]Objective To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.[/FONT]
[FONT="]Design, Setting, and Participants Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non–insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34).[/FONT]
[FONT="]Interventions All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.[/FONT]
[FONT="]Main Outcomes and Measures Primary outcome was change in hemoglobin A[SUB]1c[/SUB] (HbA[SUB]1c[/SUB]) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ?0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication.[/FONT]
[FONT="]Results Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA[SUB]1c[/SUB], 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA[SUB]1c[/SUB] level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of −0.26% [95% CI, −0.52% to −0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.[/FONT]
[FONT="]Conclusions and Relevance Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings.[/FONT]
[FONT="]Key Points[/FONT]
[FONT="]Question Can an intensive lifestyle intervention achieve glycemic control comparable with standard care in patients with type 2 diabetes?[/FONT]
[FONT="]Findings In this randomized clinical trial of 98 adults with type 2 diabetes diagnosed for less than 10 years, and which was designed to assess equivalence, the lifestyle intervention vs standard care resulted in a mean change in hemoglobin A[SUB]1c[/SUB] level of −0.31% vs −0.04%, respectively. The 95% CI around the difference (−0.52% to −0.01%) exceeded the prespecified equivalence margin of ?0.4%.[/FONT]
[FONT="]Meaning An intensive lifestyle intervention did not meet the criterion for equivalence for glycemic control, but the direction of findings suggests potential benefit.[/FONT]
[FONT="]Abstract[/FONT]
[FONT="]Importance It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.[/FONT]
[FONT="]Objective To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes.[/FONT]
[FONT="]Design, Setting, and Participants Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non–insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34).[/FONT]
[FONT="]Interventions All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months.[/FONT]
[FONT="]Main Outcomes and Measures Primary outcome was change in hemoglobin A[SUB]1c[/SUB] (HbA[SUB]1c[/SUB]) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ?0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication.[/FONT]
[FONT="]Results Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA[SUB]1c[/SUB], 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA[SUB]1c[/SUB] level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of −0.26% [95% CI, −0.52% to −0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.[/FONT]
[FONT="]Conclusions and Relevance Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings.[/FONT]