Abstract 018: Association of the Change in Physical Activity and Cardiovascular Disease Outcomes in the Look AHEAD Trial

Introduction: The Look AHEAD trial examined cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention compared to those randomly assigned to diabetes support and education (control). In a substudy, physical activity was assessed using accelerometry, which provides an opportunity to examine whether the incidence of cardiovascular disease varied by the measured change in physical activity. Hypothesis: There is a beneficial association between the 1- and 4-year change in physical activity and the pre-specified primary and secondary outcomes in participants in the Look AHEAD trial. Methods: Adults (N=1,978; 59.1±6.8 kg; 102.8±19.0 kg) with type 2 diabetes at 8 study sites, who completed physical activity was assessment using accelerometry for 1 week at 0, 1, and 4 years. MET-minutes per week of moderate-to-vigorous physical activity (MVPA) performed in bouts of at least 10 minutes was identified from the accelerometry data. The 1- and 4-year change in MVPA was computed as the difference from baseline. The primary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, and cardiovascular disease death. The first secondary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, CABG/PTCA, hospitalized congestive heart failure, carotid endarterectomy, peripheral vascular disease, and total mortality. The relationships between 1- and 4-year change in physical activity and the primary and secondary outcomes were examined using Cox proportional hazards models with data collapses across the two treatment groups. Hazard ratios (HR) were adjusted for age, sex, history of cardiovascular disease, duration of diabetes, diabetes medication use, baseline weight, change in weight, and baseline physical activity. Results: MVPA [Median (25 th , 75 th percentile)] was 167.6 (0,545.5), 205.4 (0, 700.2), and 91.3 (0, 418.9) MET-minutes per week at 0, 1 and 4 years, respectively. Change in MVPA at 1-year was not significantly associated with the primary outcome [HR per 100 MET-minutes per week = 1.001 (95% CI: 0.985, 1.017)] or secondary outcome [HR per 100 MET-minutes per week = 0.989 (95% CI: 0.966, 1.013)] assessed across 8.8±2.4 years of follow-up. Change in MVPA at 4-years was significantly associated with a reduction in the primary [HR per 100 MET-minutes per week = 0.949 (95% CI: 0.912, 0.987)] and the secondary outcome [HR per 100 MET-minutes per week = 0.897 (95% CI: 0.843, 0.954)] assessed across 9.2±1.8 years of follow-up. Conclusions: Change in physical activity at 4-years is associated with a reduction in incidence of cardiovascular disease in adults with type 2 diabetes. These findings suggest improvements in physical activity may need to be sustained for a relatively long period (4 years) to elicit a beneficial effect on incidence of cardiovascular disease.

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Association Between Change in Accelerometer-Measured and Self-Reported Physical Activity and Cardiovascular Disease in the Look AHEAD Trial

10.2337/figshare.17157926 ◽

2022 ◽

Author(s):

John M. Jakicic ◽

Robert I. Berkowitz ◽

Paula Bolin ◽

George A. Bray ◽

Jeanne M. Clark ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Proportional Hazards ◽

Secondary Analysis ◽

Cox Proportional Hazards ◽

Self Report ◽

Look Ahead ◽

The Look

OBJECTIVE: To conduct post-hoc secondary analysis examining the association between change in physical activity (PA), measured with self-report and accelerometry, from baseline to 1 and 4 years and cardiovascular disease (CVD) outcomes in the Look AHEAD Trial. RESEARCH DESIGN AND METHODS: Participants were adults with overweight/obesity and type 2 diabetes with PA data at baseline and year 1 or 4 (n = 1,978). Participants were randomized to diabetes support and education or intensive lifestyle intervention. Measures included accelerometry-measured moderate-to-vigorous PA (MVPA), self-reported PA, and composite (morbidity and mortality) CVD outcomes. RESULTS: In pooled analyses of all participants, using Cox proportional hazards models, each 100 MET-min/wk increase in accelerometry-measured MVPA from baseline to 4 years was associated with decreased risk of the subsequent primary composite outcome of CVD. Results were consistent for changes in total MVPA [HR=0.97 (95% CI: 0.95, 0.99)] and MVPA accumulated in >10-minute bouts [HR=0.95 (95% CI: 0.91, 0.98)], with a similar pattern for secondary CVD outcomes. Change in accelerometry-measured MVPA at 1 year and self-reported change in PA at 1 and 4 years were not associated with CVD outcomes. CONCLUSIONS: Increased accelerometry-measured MVPA from baseline to year 4 is associated with decreased risk of CVD outcomes. This suggests the need for long-term engagement in MVPA to reduce the risk of CVD in adults with overweight/obesity and type 2 diabetes.

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Association Between Change in Accelerometer-Measured and Self-Reported Physical Activity and Cardiovascular Disease in the Look AHEAD Trial

10.2337/figshare.17157926.v1 ◽

2022 ◽

Author(s):

John M. Jakicic ◽

Robert I. Berkowitz ◽

Paula Bolin ◽

George A. Bray ◽

Jeanne M. Clark ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Proportional Hazards ◽

Secondary Analysis ◽

Cox Proportional Hazards ◽

Self Report ◽

Look Ahead ◽

The Look

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170-OR: Association of Timing of Physical Activity Bouts with Cardiorespiratory Fitness in Adults with Type 2 Diabetes in the Look AHEAD Study

Diabetes ◽

10.2337/db20-170-or ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 170-OR

Author(s):

JINGYI QIAN ◽

MICHAEL P. WALKUP ◽

SHYH-HUEI CHEN ◽

PETER H. BRUBAKER ◽

DALE BOND ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Cardiorespiratory Fitness ◽

Look Ahead ◽

The Look

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Physical activity less than the recommended amount may prevent the onset of major biological risk factors for cardiovascular disease: a cohort study of 198 919 adults

British Journal of Sports Medicine ◽

10.1136/bjsports-2018-099740 ◽

2018 ◽

Vol 54 (4) ◽

pp. 238-244 ◽

Cited By ~ 1

Author(s):

David Martinez-Gomez ◽

Irene Esteban-Cornejo ◽

Esther Lopez-Garcia ◽

Esther García-Esquinas ◽

Kabir P Sadarangani ◽

...

Keyword(s):

Physical Activity ◽

Risk Factors ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Cvd Risk Factors ◽

Cvd Risk ◽

Highly Active ◽

Atherogenic Dyslipidaemia

ObjectivesWe examined the dose–response relationship between physical activity (PA) and incidence of cardiovascular disease (CVD) risk factors in adults in Taiwan.MethodsThis study included 1 98 919 participants, aged 18–97 years, free of CVD, cancer and diabetes at baseline (1997–2013), who were followed until 2016. At baseline, participants were classified into five PA levels: inactive’ (0 metabolic equivalent of task (MET)-h/week), ‘lower insufficiently active’ (0.1–3.75 MET-h/week), ‘upper insufficiently active’ (3.75–7.49 MET-h/week), ‘active’ (7.5–14.99 MET-h/week) and ‘highly active’ (≥15 MET-h/week]. CVD risk factors were assessed at baseline and at follow-up by physical examination and laboratory tests. Analyses were performed with Cox regression and adjusted for the main confounders.ResultsDuring a mean follow-up of 6.0±4.5 years (range 0.5–19 years), 20 447 individuals developed obesity, 19 619 hypertension, 21 592 hypercholesterolaemia, 14 164 atherogenic dyslipidaemia, 24 275 metabolic syndrome and 8548 type 2 diabetes. Compared with inactive participants, those in the upper insufficiently active (but not active) category had a lower risk of obesity (HR 0.92; 95% CI 0.88 to 0.95), atherogenic dyslipidaemia (0.96; 0.90 to 0.99), metabolic syndrome (0.95; 0.92 to 0.99) and type 2 diabetes (0.91; 0.86 to 0.97). Only highly active individuals showed a lower incidence of CVD risk factors than their upper insufficiently active counterparts.ConclusionCompared with being inactive, doing half the recommended amount of PA is associated with a lower incidence of several common biological CVD risk factors. Given these benefits, half the recommended amount of PA is an evidence based target for inactive adults.

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Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

Health Technology Assessment ◽

10.3310/hta25770 ◽

2021 ◽

Vol 25 (77) ◽

pp. 1-190

Author(s):

Kamlesh Khunti ◽

Simon Griffin ◽

Alan Brennan ◽

Helen Dallosso ◽

Melanie Davies ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Confidence Interval ◽

Primary Outcome ◽

Health Technology ◽

Accelerometer Data ◽

Ambulatory Activity ◽

Steps Per Day

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

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P4990Heterogeneity of treatment effects from an intensive lifestyle weight loss intervention on cardiovascular events in patients with type 2 diabetes: data from the Look AHEAD trial

European Heart Journal ◽

10.1093/eurheartj/ehz746.0168 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T I De Vries ◽

J A N Dorresteijn ◽

Y Van Der Graaf ◽

F L J Visseren ◽

J Westerink

Keyword(s):

Type 2 Diabetes ◽

Treatment Effect ◽

Patient Characteristics ◽

Treatment Benefit ◽

Significant Treatment ◽

Intensive Lifestyle Intervention ◽

Look Ahead ◽

The Look

Abstract Background The Action for Health in Diabetes trial (Look AHEAD) randomized overweight and obese patients with type 2 diabetes to either an intensive lifestyle intervention (ILI) or diabetes support and education (DSE). The trial was stopped early for futility after a median follow-up of 9.6 years due to a lack of effect on cardiovascular disease outcomes, despite beneficial effects on metabolic control and cardiovascular risk factors. Subgroup analyses identified no subgroups based on baseline characteristics with a significant treatment effect. However, traditional simple subgroup analyses have several disadvantages compared to a multivariable risk-based approach to identify heterogeneity of treatment effects (HTE). Purpose To explore the possible presence of HTE of an ILI on the occurrence of major cardiovascular events (4-point MACE: nonfatal myocardial infarction, nonfatal stroke, hospitalization for angina, and death from cardiovascular causes) in overweight or obese patients with type 2 diabetes mellitus, and to identify patient characteristics associated with treatment. Methods In 4,901 patients from Look AHEAD, a ridge penalized Cox regression model to predict treatment effect of ILI versus DSE on the risk of MACE was derived including all possible treatment-by-covariate interaction terms. Next, the ability of the model to predict HTE was confirmed by calculating hazard ratios (HR) and absolute risk change in quartiles of predicted treatment effect, thereby leaving randomization intact. Finally, baseline patient characteristics were compared between quartiles of predicted treatment effect. Results During a median follow-up of 9.4 years, 799 events occurred (Fig. 1A). The derived risk model showed good internal calibration, with a C-statistic for discrimination of 0.73 (95% confidence interval [95% CI] 0.71–0.73). The median estimated absolute treatment effect on 10 year risk for MACE with ILI was −1.3% and varied substantially, ranging from −39% to +43% (Fig. 1B). In quartile 1, the quartile with the highest benefit, there was a significant treatment benefit of ILI versus DSE (HR 0.64; 95% CI 0.49–0.83), while there was no effect from treatment in quartiles 2 and 3 (HR 0.81, 95% CI 0.58–1.14, and 1.13, 95% CI 0.80–1.60, respectively), and a detrimental effect in quartile 4 (HR 1.37, 95% CI 1.09–1.73) (Fig. 1C). Patient characteristics most notably associated with higher benefit of ILI were higher age, male sex, higher socio-economic status, no history of cardiovascular disease, no use of insulin, higher blood pressure, lower HbA1c, and the presence of micro-albuminuria but absence of macro-albuminuria. Figure 1 Conclusion This post-hoc analysis of the Look AHEAD trial shows evidence of considerable HTE of an intensive lifestyle intervention aimed at weight loss for reducing MACE. Future research into ILI for MACE risk reduction should be specifically aimed at subgroups of patients with a high likelihood of treatment benefit. Acknowledgement/Funding None

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Association of moderate and vigorous physical activity with incidence of type 2 diabetes and subsequent mortality: 27 year follow-up of the Whitehall II study

Diabetologia ◽

10.1007/s00125-019-05050-1 ◽

2019 ◽

Vol 63 (3) ◽

pp. 537-548 ◽

Cited By ~ 3

Author(s):

Manasa S. Yerramalla ◽

Aurore Fayosse ◽

Aline Dugravot ◽

Adam G. Tabak ◽

Mika Kivimäki ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Data Sharing ◽

Vigorous Physical Activity ◽

Health Care Research ◽

Public Health Research ◽

Diabetes Diagnosis

Abstract Aims/hypothesis This work examined the role of physical activity in the course of diabetes using data spanning nearly three decades. Our first aim was to examine the long-term association of moderate and vigorous physical activity with incidence of type 2 diabetes. Our second aim was to investigate the association of moderate-to-vigorous physical activity post-diabetes diagnosis with subsequent risk of all-cause and cardiovascular disease mortality. Methods A total of 9987 participants from the Whitehall II cohort study free of type 2 diabetes at baseline (1985–1988) were followed for incidence of type 2 diabetes, based on clinical assessments between 1985 and 2016 and linkage to electronic health records up to 31 March 2017. We first examined the association of moderate and vigorous physical activity measured by questionnaire in 1985–1988 (mean age 44.9 [SD 6.0] years; women, 32.7%) with incident type 2 diabetes, using the interval-censored, illness–death model, a competing risk analysis that takes into account both competing risk of death and intermittent ascertainment of diabetes due to reliance on data collection cycles (interval-censored). The second analysis was based on individuals with type 2 diabetes over the follow-up period where we used Cox regression with inverse probability weighting to examine the association of moderate-to-vigorous physical activity after diagnosis of type 2 diabetes with risk of all-cause and cardiovascular disease mortality. Results Of the 9987 participants, 1553 developed type 2 diabetes during a mean follow-up of 27.1 (SD 6.3) years. Compared with participants who were inactive in 1985–1988, those who undertook any duration of moderate-to-vigorous physical activity had a lower risk of type 2 diabetes (HR 0.85 [95% CI 0.75, 0.97], p = 0.02; analysis adjusted for sociodemographic, behavioural and health-related factors). In 1026 participants with a diagnosis of type 2 diabetes over the follow-up period, data on moderate-to-vigorous physical activity after diabetes diagnosis were available; 165 all-cause deaths and 55 cardiovascular disease-related deaths were recorded during a mean follow-up of 8.8 (SD 6.1) years. In these participants with diabetes, any duration of moderate-to-vigorous physical activity was associated with lower all-cause mortality (HR 0.61 [95% CI 0.41, 0.93], p = 0.02) while the association with cardiovascular mortality was evident only for physical activity undertaken at or above recommendations (≥2.5 h per week of moderate-to-vigorous physical activity or ≥1.25 h per week of vigorous physical activity; HR 0.40 [95% CI 0.16, 0.96], p = 0.04) in fully adjusted models. Conclusions/interpretation Moderate-to-vigorous physical activity plays an important role in diabetes, influencing both its incidence and prognosis. A protective effect on incidence was seen for durations of activity below recommendations and a marginal additional benefit was observed at higher durations. Among individuals with type 2 diabetes, any duration of moderate-to-vigorous physical activity was associated with reduced all-cause mortality while recommended durations of physical activity were required for protection against cardiovascular disease-related mortality. Data availability Whitehall II data, protocols and other metadata are available to the scientific community. Please refer to the Whitehall II data sharing policy at https://www.ucl.ac.uk/epidemiology-health-care/research/epidemiology-and-public-health/research/whitehall-ii/data-sharing.

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A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study (Preprint)

10.2196/preprints.12965 ◽

2018 ◽

Author(s):

David Koot ◽

Paul Soo Chye Goh ◽

Robyn Su May Lim ◽

Yubing Tian ◽

Teng Yan Yau ◽

...

Keyword(s):

Type 2 Diabetes ◽

Feasibility Study ◽

User Satisfaction ◽

Primary Outcome ◽

Management Program ◽

Secondary Outcome ◽

Lifestyle Management ◽

Program Engagement

BACKGROUND Singapore’s current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective for reducing the risks for complications of type 2 diabetes mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health apps can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions. OBJECTIVE Using the RE-AIM evaluation framework, this study assessed the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care. METHODS This single-arm feasibility study recruited 100 patients with T2DM and glycated hemoglobin (HbA1c) levels of ≥7.5% from a single community health care facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco mobile phone app with a health coaching feature. The GlycoLeap program was evaluated using 4 relevant dimensions of the RE-AIM framework: (1) reach (percentage who consented to participate out of all patients approached), (2) effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) implementation (program engagement as assessed by various participatory metrics), and (4) maintenance (postintervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention). RESULTS A total of 785 patients were approached of whom 104 consented to participate, placing the reach at 13.2%. Four were excluded after eligibility screening, and 100 patients were recruited. Program engagement (implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (implementation). Primary outcome data were available for 83 participants. Statistically significant improvements were observed for HbA1c (–1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (effectiveness). User satisfaction was high with 74% (59/80) and 79% (63/80) of participants rating the app good or very good and claiming that they would probably or definitely recommend the app to others, respectively (maintenance). CONCLUSIONS Although measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months. CLINICALTRIAL ClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn)

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Abstract 16: Association of Baseline & Longitudinal Changes in Fitness & Body Mass Index With Risk of Heart Failure in Individuals With Type 2 Diabetes Mellitus: An Analysis From the Look Ahead Trial

Circulation ◽

10.1161/circ.141.suppl_1.16 ◽

2020 ◽

Vol 141 (Suppl_1) ◽

Cited By ~ 1

Author(s):

Ambarish Pandey ◽

Kershaw Patel ◽

Judy Bahnson ◽

Darren K McGuire ◽

Jarett D Berry ◽

...

Keyword(s):

Type 2 Diabetes ◽

Weight Loss ◽

Ejection Fraction ◽

Lower Risk ◽

Preserved Ejection Fraction ◽

Look Ahead ◽

The Look ◽

Study Participants

Introduction: Type 2 Diabetes (T2DM) is associated with higher risk for HF. The contributions of baseline measures of and changes in fitness (CRF) toward HF risk in T2DM is not well-established. Methods: Participants of the Look AHEAD trial without prevalent HF randomized to the intensive lifestyle intervention (ILI) vs. usual care arms were included. Incident HF hospitalization and its subtypes [HF with preserved ejection fraction (EF>= 50%, HFpEF) & HF with preserved ejection fraction (EF < 50%, HFrEF)] were adjudicated through the end of 2014 using a validated approach. The associations of baseline CRF estimated from a maximal treadmill test and changes in CRF (from baseline to year 4) with risk of HF and its subtypes were evaluated using adjusted Cox models. Results: Among the 5,109 study participants, there was no significant difference in the risk of HF (n = 257 events) between the ILI vs. usual care groups [HR (95% CI) = 0.96 (0.75 - 1.23)] over 12.4 years follow up. In adjusted analysis, the risk of HF was 39% and 62% lower among moderate fit [Tertile 2] and high fit [Tertile 3] groups, respectively [vs. low fit (Tertile 1), Table]. Among HF subtypes, the risk of HFpEF was 40% lower in moderate fit and 77% lower in the high fit groups (vs. low fit). In contrast, baseline CRF was not associated with risk of HFrEF after adjustment for potential confounders (Table). BMI was also not associated with risk of HF after adjustment for CV risk factors. Among participants with repeat CRF testing (n = 3,902), improvements in CRF and weight loss over 4-year follow-up was significantly associated with lower risk of HF [HR (95% CI) per 10% increase in CRF = 0.90 (0.82 to 0.99), per 10% decrease in BMI = 0.80 (0.69 to 0.94)]. Conclusion: Higher baseline CRF is independently associated with lower risk of HF, particularly HFpEF, among individuals with T2DM. Improvements in CRF and weight loss can significantly lower risk of HF in this high-risk population. However, the ILI implemented in the LookAHEAD trial did not modify the risk of HF among the study participants.

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