Changes in Prediabetes Status Among Adults During a 6-Month Randomized Placebo-controlled Supplement Trial With Nutrition and Lifestyle Counselling and 6-Month Follow-up

Can J Diabetes. 2023 Oct;47(7):571-578. doi: 10.1016/j.jcjd.2023.05.004. Epub 2023 May 13.

Abstract

Objectives: In this work, we present an exploratory within-trial analysis of the changing prevalence of prediabetes in response to nutrition and lifestyle counselling provided as part of a randomized placebo-controlled supplement trial with follow-up. We aimed to identify factors associated with changing glycemia status.

Methods: Participants (n=401) in this clinical trial were adults with a body mass index (BMI) of ≥25 kg/m2 and prediabetes (defined by the American Diabetes Association as a fasting plasma glucose [FPG] of 5.6 to 6.9 mmol/L or a glycated hemoglobin [A1C] of 5.7% to 6.4%) within 6 months before trial entry. The trial consisted of a 6-month randomized intervention with 2 dietary supplements and/or placebo. At the same time, all participants received nutrition and lifestyle counselling. This was followed by a 6-month follow-up. Glycemia status was assessed at baseline and at 6 and 12 months.

Results: At baseline, 226 participants (56%) met a threshold for prediabetes, including 167 (42%) with elevated FPG and 155 (39%) with elevated A1C. After the 6-month intervention, the prevalence of prediabetes decreased to 46%, driven by a reduction in prevalence of elevated FPG to 29%. The prevalence of prediabetes then increased to 51% after follow-up. Risk of prediabetes was associated with older age (odds ratio [OR], 1.05; p<0.01), BMI (OR, 1.06; p<0.05), and male sex (OR, 1.81; p=0.01). Participants who reverted to normoglycemia had greater weight loss and lower baseline glycemia.

Conclusions: Glycemia status can fluctuate over time and improvements can be gained from lifestyle interventions, with certain factors associated with a higher likelihood of reverting to normoglycemia.

Keywords: A1C; HbA1c; clinical trial; essai clinique; fasting plasma glucose; glycémie veineuse à jeun; interventions axées sur le mode de vie; lifestyle intervention; normoglycemia; normoglycémie; prediabetes; prédiabète.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Glucose
  • Counseling
  • Dietary Supplements
  • Follow-Up Studies
  • Glycated Hemoglobin
  • Humans
  • Life Style
  • Male
  • Prediabetic State* / epidemiology
  • Prediabetic State* / therapy

Substances

  • Glycated Hemoglobin
  • Blood Glucose