Regression from prediabetes (preD) to normoglycemia (NG) is associated with reduced progression to type 2 diabetes (T2D). Carbohydrate restriction including nutritional ketosis (CR) has emerged as a safe, effective, and sustainable treatment for regression of hyperglycemia in T2D, yet its multi-year effects on preD are unknown. Also, some patients have difficulty initiating and/or sustaining provider-recommended lifestyle changes. Thus, we hypothesized that a remotely delivered continuous care intervention (CCI) emphasizing CR would improve glycemia and weight in patients with preD. In a single-arm, prospective, longitudinal study, we assessed incidence of regression from preD to NG, progression from preD to T2D, and prevalence of metabolic syndrome (MetS) and class II or greater obesity in participants following two years of treatment. Patients with a preD diagnosis enrolled in the study (n=116). Outcomes were assessed among 96 participants (age: 52±10 y; BMI: 39.2±7.1 kg/m2) with preD defined as HbA1c<6.5% with metformin use or HbA1c 5.7-6.4% (inclusive) without glycemic control medication. Retention at two years was 75% (72/96). The crude incidence for first occurrence of regression from preD to NG (HbA1c <5.7% without medication) was 47.6 cases per 100 person-years. Estimated cumulative incidence of NG at two years was 52.3%. One new case of T2D each year was observed, and crude incidence of T2D diagnosis was 1.5 cases per 100 person-years. Estimated cumulative incidence of T2D at two years was 3%. Prevalence of MetS was reduced from 94% to 30% at one and 47% at two years (both P<4.4x10-16). Prevalence of class II or greater obesity was reduced from 67% to 38% at one and 39% at two years (both P<.0013). Among two-year completers, 62.5% achieved ≥7% weight loss. Given these observations, this study demonstrates the potential utility of a CCI emphasizing CR for treatment of preD.

Disclosure

A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. S.J. Athinarayanan: Employee; Self; Virta Health Corp. J. McCue: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp. R.N. Adams: Employee; Self; Virta Health Corp. J.P. McCarter: Employee; Self; Abbott Laboratories. Stock/Shareholder; Self; Virta Health. J. Volek: Advisory Panel; Self; Atkins Nutritionals, Cook Keto, Virta Health Corp. Stock/Shareholder; Self; PangeaKeto, Virta Health Corp. Other Relationship; Self; Beyond Obesity.

Funding

Virta Health Corp

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