Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial

Kraus, W. E., Yates, T., Tuomilehto, J., Sun, J.-L., Thomas, L., McMurray, J. J.V. , Bethel, M. A. and Holman, R. R. (2018) Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial. BMJ Open Diabetes Research and Care, 6, e000523. (doi: 10.1136/bmjdrc-2018-000523) (PMID:30073088) (PMCID:PMC6067333)

Abstract

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.

• Item Type: Articles
• Additional Information: Funding: The NAVIGATOR study was supported by Novartis, Inc. TY is supported by the NIHR Diet, Lifestyle and Physical Activity Biomedical Research Unit, Leicester, UK. WEK was supported by NIDDK/NIA grant DK081559 for purposes of this project.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McMurray, Professor John
• Authors: Kraus, W. E., Yates, T., Tuomilehto, J., Sun, J.-L., Thomas, L., McMurray, J. J.V., Bethel, M. A., and Holman, R. R.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: BMJ Open Diabetes Research and Care
• Publisher: BMJ Publishing Group
• ISSN: 2052-4897
• ISSN (Online): 2052-4897
• Published Online: 19 July 2018
• Copyright Holders: Copyright © Authors (or their employers) 2018
• First Published: First published in BMJ Open Diabetes Research and Care 6:e000523
• Publisher Policy: Reproduced under a Creative Commons license