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Cited by 37Diet and metabolism studiesDietary Effects on HealthDiabetes Management and Research

Type 2 Diabetes Prevention Focused on Normalization of Glycemia: A Two-Year Pilot Study

Open access
McKenzie, Amy L, Athinarayanan, Shaminie J, McCue, Jackson J, Adams, Rebecca N, Keyes, Monica, McCarter, James P, Volek, Jeff S, Phinney, Stephen D +1 more·2021·Nutrients
DOI 10.3390/nu13030749PMC PMC7996820
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Abstract

The purpose of this study is to assess the effects of an alternative approach to type 2 diabetes prevention. Ninety-six patients with prediabetes (age 52 (10) years; 80% female; BMI 39.2 (7.1) kg/m2) received a continuous remote care intervention focused on reducing hyperglycemia through carbohydrate restricted nutrition therapy for two years in a single arm, prospective, longitudinal pilot study. Two-year retention was 75% (72 of 96 participants). Fifty-one percent of participants (49 of 96) met carbohydrate restriction goals as assessed by blood beta-hydroxybutyrate concentrations for more than one-third of reported measurements. Estimated cumulative incidence of normoglycemia (HbA1c < 5.7% without medication) and type 2 diabetes (HbA1c ≥ 6.5% or <6.5% with medication other than metformin) at two years were 52.3% and 3%, respectively. Prevalence of metabolic syndrome, class II or greater obesity, and suspected hepatic steatosis significantly decreased at two years. These results demonstrate the potential utility of an alternate approach to type 2 diabetes prevention, carbohydrate restricted nutrition therapy delivered through a continuous remote care model, for normalization of glycemia and improvement in related comorbidities.

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  • Of 5 PHT studies on T2DM prevention, 1 (20%) posted a positive effect and 4 (80%) reported a neutral effect.

    “Of the 5 (13.5%) studies on PHT reporting its effects on preventing T2DM, 1 (20%) study [39] posted a positive effect, with 4 (80%) other studies [35,36,40,41] reporting a neutral effect on T2DM development.”

    From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [36]

    The Results (section 3.2) report a 3% cumulative incidence of type 2 diabetes at two years and a 52.3% incidence of normoglycemia, supporting a promising prevention finding. But this was a single-arm pilot study; the Discussion says it was not designed to establish superiority over other interventions and calls for further research on diabetes prevention. It therefore does not establish the positive effect on T2DM development implied by the citing sentence. The counts and percentages of studies are the citing authors’ classification, not a finding attributed to this paper. (LLM, conf=0.86)

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  • Of 16 PPC studies, 2 reviewing T2DM prevention showed a neutral effect, with no significant difference in T2DM diagnosis compared to the control group.

    “Of 16 (30.2%) studies, 2 (12.5%) studies reviewing the effects of PPC on T2DM prevention were by Fitzpatrick et al [35] and McKenzie et al [36]. Results showed a neutral effect, with no significant difference in the T2DM diagnosis compared to the control group.”

    From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [36]

    The Results (section 3.3) say that type 2 diabetes prevalence was unchanged from baseline after correction for multiple comparisons. But the Methods (section 2.1) describe a single-arm study, so McKenzie et al. did not find a nonsignificant difference in diagnoses compared with a control group. (LLM, conf=0.88)

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Authors
McKenzie, A. L., Athinarayanan, S. J., McCue, J. J., Adams, R. N., Keyes, M., McCarter, J. P., Volek, J. S., Phinney, S. D., & Hallberg, S. J.
Affiliations
  • Virta Health, San Francisco, CA 94105, USA
  • University of Washington (US)
  • Indiana University Health (US)
  • Washington University in St. Louis (US)
  • The Ohio State University (US)
Corresponding author
McKenzie, Amy L
ORCID
Venue
Nutrients
Publisher
MDPI AG
Published
2021-02-26
Volume
13
Issue
3
Pages
749
ISSN
2072-6643 (ISSN-L)
DOI
10.3390/nu13030749
PMC
PMC7996820
OpenAlex
W3134451425
Cited by
37
References
32
Citations by year
2026: 8 · 2025: 5 · 2024: 7 · 2023: 6 · 2022: 2 · 2021: 9
FWCI
3.77
Type
journal article
Language
en
Open access
Licence
Locations
  • Nutrients (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Virta Health (none)
Topics
  • Health Sciences › Medicine › Physiology › Diet and metabolism studies
  • Health Sciences › Medicine › Physiology › Dietary Effects on Health
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
type 2 diabetes prevention, carbohydrate restriction, ketogenic diet, beta-hydroxybutyrate, HbA1c, metabolic syndrome, obesity, hepatic steatosis, participant retention
MeSH terms
Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Fatty Liver, Female, Glycated Hemoglobin, Humans, Hyperglycemia, Longitudinal Studies, Male, Middle Aged, Obesity, Patient Education as Topic, Pilot Projects, Prediabetic State, Prospective Studies, Prevalence, Treatment Outcome, Telemedicine, 3-Hydroxybutyric Acid, Metabolic Syndrome, Diet, Carbohydrate-Restricted, Young Adult

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