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Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis at One Year: An Open Label, Non-Randomized, Controlled Study

View ORCID ProfileNasir H. Bhanpuri, Sarah J. Hallberg, Paul T. Williams, Amy L. McKenzie, Kevin D. Ballard, Wayne W. Campbell, James P. McCarter, Stephen D. Phinney, Jeff S. Volek
doi: https://doi.org/10.1101/262709
Nasir H. Bhanpuri
1Virta Health, San Francisco, CA, USA
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  • ORCID record for Nasir H. Bhanpuri
Sarah J. Hallberg
1Virta Health, San Francisco, CA, USA
2Indiana University Health Arnett, Medically Supervised Weight Loss, Lafayette, IN, USA
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Paul T. Williams
3Independent Consultant, Lafayette, CA, USA
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Amy L. McKenzie
1Virta Health, San Francisco, CA, USA
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Kevin D. Ballard
4Miami University, Oxford, OH, USA
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Wayne W. Campbell
5Purdue University, West Lafayette, IN, USA
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James P. McCarter
1Virta Health, San Francisco, CA, USA
6Washington University School of Medicine, Department of Genetics, St. Louis, MO, USA
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Stephen D. Phinney
1Virta Health, San Francisco, CA, USA
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Jeff S. Volek
1Virta Health, San Francisco, CA, USA
7The Ohio State University, Department of Human Sciences, Columbus, OH, USA
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Abstract

Background

Cardiovascular disease (CVD) is a leading cause of death among adults with type 2 diabetes mellitus (T2D). We recently reported that glycemic control in patients with T2D can be significantly improved through a continuous care intervention (CCI) including nutritional ketosis. The purpose of this study was to examine CVD risk factors in this cohort.

Methods

We investigated CVD risk factors in patients with T2D who participated in a one year open label, non-randomized, controlled study. The CCI group (n = 262) received treatment from a health coach and medical provider. A usual care (UC) group (n = 87) was independently recruited to track customary T2D progression. Circulating biomarkers of cholesterol metabolism and inflammation, blood pressure (BP), carotid intima media thickness (cIMT), multi-factorial risk scores and medication use were examined.

Results

The CCI group consisted of 262 patients (baseline mean(SD): age 54(8) y, BMI 40.4(8.8) kg/m2). Intention-to-treat analysis (% change) revealed the following at 1-year with P values < 0.0019 indicating statistical significance after adjustment for multiple comparisons: total LDL-particles (LDL-P) (−4.9%, P=0.02), small LDL-P (−20.8%, P=1.2×10−12), LDL-P size (+1.1%, P=6.0×10−10), ApoB (−1.6%, P=0.37), ApoA1 (+9.8%, P<10−16), ApoB/ApoA1 ratio (−9.5%, P=1.9×10−7), triglyceride/HDL-C ratio (−29.1%, P<10−16), large VLDL-P (−38.9%, P=4.2×10−15), and LDL-C (+9.9%, P=4.9×10−5). Additional effects were reductions in blood pressure, high sensitivity C-reactive protein, and white blood cell count (all P<1×10−7) while cIMT was unchanged. The 10-year atherosclerotic cardiovascular disease (ASCVD) risk score decreased −11.9% (P=4.9×10−5). Antihypertensive medication use was discontinued in 11.4 % of CCI participants (P=5.3×10−5). The UC group of 87 patients (baseline mean(SD): age 52(10)y, BMI 36.7(7.2) kg/m2) showed no significant changes. After adjusting for baseline differences when comparing CCI and UC groups, significant improvements for the CCI group included small LDL-P, ApoA1, triglyceride/HDL-C ratio, HDL-C, hs-CRP, and ASCVD score. The CCI group showed a greater rise in LDL-C.

Conclusions

A continuous care treatment including nutritional ketosis in patients with T2D improved most biomarkers of CVD risk after one year. The increase in LDL-cholesterol appeared limited to the large LDL subfraction. LDL particle size increased, total LDL-P and ApoB were unchanged, and inflammation and blood pressure decreased.

Trial registration

Clinicaltrials.gov: NCT02519309. Registered 10 August 2015

  • List of abbreviations

    ACE
    angiotensin-converting-enzyme inhibitors
    ApoA1
    apolipoprotein A1
    ApoB
    apolipoprotein B
    ARB
    angiotensin II receptor blockers
    ASCVD risk score
    10-year atherosclerotic cardiovascular disease risk score
    BHB
    beta-hydroxybutyrate
    BP
    blood pressure
    CCI
    continuous care intervention
    CCI-onsite
    subset of CCI participants who selected to receive onsite education
    CCI-web
    subset of CCI participants who selected to receive web-based education
    cIMT
    carotid intima media thickness
    CVD
    cardiovascular disease
    GDR
    glucose disposal rate
    HOMA-IR
    homeostatic model assessment of insulin resistance
    hsCRP
    high sensitive C-reactive protein
    LP-IR
    lipoprotein insulin resistance score
    T2D
    type 2 diabetes
    UC
    usual care
    VLDL-P
    very low-density lipoprotein particle number
    WBC
    white blood cell
  • Copyright 
    The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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    Posted February 15, 2018.
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    Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis at One Year: An Open Label, Non-Randomized, Controlled Study
    Nasir H. Bhanpuri, Sarah J. Hallberg, Paul T. Williams, Amy L. McKenzie, Kevin D. Ballard, Wayne W. Campbell, James P. McCarter, Stephen D. Phinney, Jeff S. Volek
    bioRxiv 262709; doi: https://doi.org/10.1101/262709
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    Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis at One Year: An Open Label, Non-Randomized, Controlled Study
    Nasir H. Bhanpuri, Sarah J. Hallberg, Paul T. Williams, Amy L. McKenzie, Kevin D. Ballard, Wayne W. Campbell, James P. McCarter, Stephen D. Phinney, Jeff S. Volek
    bioRxiv 262709; doi: https://doi.org/10.1101/262709

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