Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Mette Yun Johansen; Christopher Scott MacDonald; Katrine Bagge Hansen; Kristian Karstoft; Robin Christensen; Maria Pedersen; Louise Seier Hansen; Morten Zacho; Anne-Sophie Wedell-Neergaard; Signe Tellerup Nielsen; Ulrik Wining Iepsen; Henning Langberg; Allan Arthur Vaag; Bente Klarlund Pedersen; Mathias Ried-Larsen

doi:10.1001/jama.2017.10169

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Mette Yun Johansen, Christopher Scott MacDonald, Katrine Bagge Hansen, Kristian Karstoft, Robin Christensen, Maria Pedersen, Louise Seier Hansen, Morten Zacho, Anne-Sophie Wedell-Neergaard, Signe Tellerup Nielsen, Ulrik Wining Iepsen, Henning Langberg, Allan Arthur Vaag, Bente Klarlund Pedersen, Mathias Ried-Larsen

Institut for Klinisk Medicin

61 Citationer (Scopus)

Abstract

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.

Originalsprog	Engelsk
Tidsskrift	J A M A: The Journal of the American Medical Association
Vol/bind	318
Udgave nummer	7
Sider (fra-til)	637-646
ISSN	0098-7484
DOI	https://doi.org/10.1001/jama.2017.10169
Status	Udgivet - 15 aug. 2017

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10.1001/jama.2017.10169

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Johansen, M. Y., MacDonald, C. S., Hansen, K. B., Karstoft, K., Christensen, R., Pedersen, M., Hansen, L. S., Zacho, M., Wedell-Neergaard, A-S., Nielsen, S. T., Iepsen, U. W., Langberg, H., Vaag, A. A., Pedersen, B. K., & Ried-Larsen, M. (2017). Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J A M A: The Journal of the American Medical Association, 318(7), 637-646. https://doi.org/10.1001/jama.2017.10169

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes : A Randomized Clinical Trial. / Johansen, Mette Yun; MacDonald, Christopher Scott; Hansen, Katrine Bagge et al.

I: J A M A: The Journal of the American Medical Association, Bind 318, Nr. 7, 15.08.2017, s. 637-646.

Publikation: Bidrag til tidsskrift › Letter › peer review

Johansen, MY, MacDonald, CS, Hansen, KB, Karstoft, K, Christensen, R, Pedersen, M, Hansen, LS, Zacho, M, Wedell-Neergaard, A-S, Nielsen, ST, Iepsen, UW, Langberg, H, Vaag, AA , Pedersen, BK & Ried-Larsen, M 2017, 'Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial', J A M A: The Journal of the American Medical Association, bind 318, nr. 7, s. 637-646. https://doi.org/10.1001/jama.2017.10169

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title = "Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial",

abstract = "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.",

keywords = "Adult, Aged, Caloric Restriction, Counseling, Diabetes Mellitus, Type 2, Exercise, Female, Glycated Hemoglobin A, Humans, Hypoglycemic Agents, Intention to Treat Analysis, Life Style, Male, Middle Aged, Single-Blind Method, Weight Loss, Comparative Study, Journal Article, Randomized Controlled Trial",

author = "Johansen, {Mette Yun} and MacDonald, {Christopher Scott} and Hansen, {Katrine Bagge} and Kristian Karstoft and Robin Christensen and Maria Pedersen and Hansen, {Louise Seier} and Morten Zacho and Anne-Sophie Wedell-Neergaard and Nielsen, {Signe Tellerup} and Iepsen, {Ulrik Wining} and Henning Langberg and Vaag, {Allan Arthur} and Pedersen, {Bente Klarlund} and Mathias Ried-Larsen",

year = "2017",

month = aug,

day = "15",

doi = "10.1001/jama.2017.10169",

language = "English",

volume = "318",

pages = "637--646",

journal = "J A M A: The Journal of the American Medical Association",

issn = "0098-7484",

publisher = "American Medical Association",

number = "7",

}

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 -

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial

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