Accounting for concurrent antihyperglycemic medication changes in dietary and physical activity interventions: A focused literature review

Author:

Campbell Dennis B1ORCID,Lee Olstad Dana2,Donald Teagan3,Campbell David JT245ORCID

Affiliation:

1. Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada

2. Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

3. Sauder School of Business, University of British Columbia, Vancouver, BC, Canada

4. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

5. Department of Cardiac Sciences, Cumming School of Medicine, University of Calgaryy, Calgary, AB, Canada

Abstract

Aims To summarize methods used to account for antihyperglycemic medication changes in randomized controlled trials evaluating the effect of dietary and physical activity interventions on glycemia among adults with diabetes. Methods Using studies included in two recently published systematic reviews of randomized controlled trials examining the glycemic effects of dietary and physical activity interventions, we evaluated how each study accounted for antihyperglycemic medication changes. Data were analyzed using summary statistics, stratified by the type of intervention studied, and each was assigned a score from 0 to 6 reflecting the strength of medication controls employed. Results We evaluated 22 physical activity focused and 27 dietary focused articles. Our scoring system yielded a mean concurrent medication adjustment score of 3.9/6 for the physical activity studies and a score of 1.7/6 ( p < 0.001) for the dietary studies. Conclusions We found that randomized controlled trials included in recent systematic reviews of physical activity and dietary interventions did not robustly account or control for changes in antihyperglycemic medications, with physical activity interventions doing so more robustly than dietary interventions. This is a threat to the validity of study findings, as observed glycemic changes may in fact be attributable to imbalances in concurrent medication adjustments between groups.

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference5 articles.

1. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of Diabetes Mellitus. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus-revision_en.pdf. (accessed 9 November 2021).

2. Government of Canada. Guidance for Industry: standards for clinical trials in type 2 diabetes in Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/guidance-industry-standards-clinical-trials-type-2-diabetes-canada.html#a21. (accessed 9 November 2021).

3. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis

4. Improving type 2 diabetes mellitus glycaemic control through lifestyle modification implementing diet intervention: a systematic review and meta-analysis

5. Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies

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