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, 6 (1), e000523

Relationship Between Baseline Physical Activity Assessed by Pedometer Count and New-Onset Diabetes in the NAVIGATOR Trial


Relationship Between Baseline Physical Activity Assessed by Pedometer Count and New-Onset Diabetes in the NAVIGATOR Trial

William E Kraus et al. BMJ Open Diabetes Res Care.


Objective: Physical activity is related to clinical outcomes, even after adjusting for body mass, but is rarely assessed in randomized clinical trials.

Research design and methods: We conducted an observational analysis of data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial, in which a total of 9306 people from 40 countries with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors were randomized to receive nateglinide or placebo, in a 2-by-2 factorial design with valsartan or placebo. All were asked to also participate in a detailed lifestyle modification programme and followed-up for a median of 6.4 years with progression to diabetes as a co-primary end point. Seven-day ambulatory activity was assessed at baseline using research-grade pedometers. We assessed whether the baseline amount of physical activity was related to subsequent development of diabetes in individuals with impaired glucose tolerance.

Results: Pedometer data were obtained on 7118 participants and 35.0% developed diabetes. In an unadjusted analysis each 2000-step increment in the average number of daily steps, up to 10 000, was associated with a 5.5% lower risk of progression to diabetes (HR 0.95, 95%CI 0.92 to 0.97), with >6% relative risk reduction after adjustment.

Conclusions: Physical activity should be measured objectively in pharmacologic trials as it is a significant but underappreciated contributor to diabetes outcomes. It should be a regular part of clinical practice as well.

Keywords: diabetes mellitus; exercise, physical activity; prediabetes.

Conflict of interest statement

Competing interests: TY: Research support from the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre and the NIHR Collaboration for Leadership in Applied Health Research and Care, East Midlands. MAB: Research support from Merck Serono; attended advisory boards with Boehringer Ingelheim, AstraZeneca, and Novo Nordisk. Her department has received research funding from Merck, Amylin, Lilly, and BMS. RRH: Research support from Amylin, Bayer, Merck, and Novartis; attended advisory boards with Amylin, Lilly, Merck, Novartis, and Novo Nordisk; and given lectures supported by Bayer, Lilly, Merck, and Novo Nordisk.


Figure 1
Figure 1
Kaplan-Meier survival curves for the development of diabetes by quartiles of baseline pedometer steps. Probabilities of diabetes mellitus (DM) curves were compared using log-rank test (P<0.0001). Individuals at risk at each visit of follow-up were: 9306 (V0), 8230 (V1), 7524 (V2), 7178 (V3), 6582 (V4), 6229 (V5), 5572 (V6), 4876 (V7), 4275 (V8), 2931 (V9), and 510 (V10).

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