TY - JOUR
T1 - Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes
T2 - A Randomized Clinical Trial
AU - Johansen, Mette Yun
AU - MacDonald, Christopher Scott
AU - Hansen, Katrine Bagge
AU - Karstoft, Kristian
AU - Christensen, Robin
AU - Pedersen, Maria
AU - Hansen, Louise Seier
AU - Zacho, Morten
AU - Wedell-Neergaard, Anne-Sophie
AU - Nielsen, Signe Tellerup
AU - Iepsen, Ulrik Wining
AU - Langberg, Henning
AU - Vaag, Allan Arthur
AU - Pedersen, Bente Klarlund
AU - Ried-Larsen, Mathias
PY - 2017/8/15
Y1 - 2017/8/15
N2 - Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.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.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).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.Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) 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.Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c 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.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.Trial Registration: clinicaltrials.gov Identifier: NCT02417012.
AB - Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes.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.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).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.Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) 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.Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c 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.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.Trial Registration: clinicaltrials.gov Identifier: NCT02417012.
KW - Adult
KW - Aged
KW - Caloric Restriction
KW - Counseling
KW - Diabetes Mellitus, Type 2
KW - Exercise
KW - Female
KW - Glycated Hemoglobin A
KW - Humans
KW - Hypoglycemic Agents
KW - Intention to Treat Analysis
KW - Life Style
KW - Male
KW - Middle Aged
KW - Single-Blind Method
KW - Weight Loss
KW - Comparative Study
KW - Journal Article
KW - Randomized Controlled Trial
U2 - 10.1001/jama.2017.10169
DO - 10.1001/jama.2017.10169
M3 - Letter
C2 - 28810024
SN - 0098-7484
VL - 318
SP - 637
EP - 646
JO - J A M A: The Journal of the American Medical Association
JF - J A M A: The Journal of the American Medical Association
IS - 7
ER -
