Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial
Open accessAbstract
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.
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The NAVIGATOR study has shown that for every additional 2000 steps/day the risk of developing cardiovascular events decreased by 10%, T2DM by 5.5%, and the metabolic syndrome risk score reduced by 0.29 z-score.
“In addition, the NAVIGATOR study, which consisted of 9000 individuals with high cardiovascular risk or impaired glucose tolerance, has shown that for every additional 2000 steps/day the risk of developing cardiovascular events decreased by 10%, T2DM by 5.5%, and the metabolic syndrome risk score redcued by 0.29 z-score [70–72].”
From Can consumer wearable activity tracker-based interventions improve physical activity and cardiometabolic health in patients with chronic diseases? A systematic review and meta-analysis of randomised controlled trials (2020) · cites this paper as [71]
The Research design and methods section reports 9,306 participants with impaired glucose tolerance and cardiovascular disease or risk factors. The Conclusions report a 5.5% lower diabetes risk per 2,000 additional baseline steps per day. This paper does not report the claimed 10% reduction in cardiovascular events or 0.29 z-score reduction in metabolic syndrome risk; its Discussion mentions a cardiovascular association without that figure. Page numbers were unavailable in our copy. (LLM, conf=0.88)
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- Authors
- Kraus, W. E., Yates, T., Tuomilehto, J., Sun, J.-L., Thomas, L., McMurray, J. J. V., Bethel, M. A., & Holman, R. R.
- Affiliations
- Duke University (US)
- University of Leicester (GB)
- Universität für Weiterbildung Krems (AT)
- University of Glasgow (GB)
- University of Oxford (GB)
- Corresponding author
- Kraus, William E
- ORCID
- Venue
- BMJ Open Diabetes Research & Care
- Publisher
- BMJ
- Published
- 2018-07
- Volume
- 6
- Issue
- 1
- Pages
- e000523
- ISSN
- 2052-4897 (ISSN-L)
- PMC
- PMC6067333
- OpenAlex
- W2883142186
- Cited by
- 59
- References
- 24
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 6 · 2023: 2 · 2022: 12 · 2021: 8 · 2020: 14 · 2019: 10
- FWCI
- 5.50
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open Diabetes Research & Care (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- Research Bank (Australian Catholic University) (submittedVersion, cc-by-nc)
- Figshare (submittedVersion, cc-by-nc)
- Työväentutkimus Vuosikirja (submittedVersion)
- Leicester Research Archive (University of Leicester) (submittedVersion, cc-by-nc)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK081559)
- Topics
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- physical activity, pedometers, step count, impaired glucose tolerance, new-onset diabetes, diabetes progression, nateglinide, valsartan, lifestyle modification, cardiovascular risk, objective activity measurement
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