212-OR: Five-Year Follow-Up of Lipid, Inflammatory, Hepatic, and Renal Markers in People with T2 Diabetes on a Very-Low-Carbohydrate Intervention Including Nutritional Ketosis (VLCI) via Continuous Remote Care (CRC)

Abstract

Objective: To address the long-term effectiveness of VLCI for T2D, we report changes in lipids, inflammatory, hepatic, and renal markers at 5y. Research Design and Methods: Of the 200 subjects with T2D reaching 2-years in a non-randomized, controlled trial of CRC emphasizing VLCI, 169 (84.5%) consented to 3-year extension and 122 (61%) completed 5y. Metabolic changes from baseline (BL) to 5y were assessed with linear mixed effect models as an intent-to-treat analysis (n=169) . Holm-Bonferroni adjusted p-values are <0.05 unless otherwise noted. Results: At 5y, there were significant changes in HDLc from 43.0 mg/dl to 50.6 mg/dl (+17.7%) , apoA-I from 146.9 mg/dl to 153.5 mg/dl (+4.5%) , and no changes in Total Cholesterol, LDLc, apoB. There were marginal improvements in non-HDLc from 139.2 mg/dl to 128.9 mg/dl (-7.4%, unadjusted p-value <0.01) , and triglycerides from 202.3 mg/dl to 165.1 mg/dl (-18.4%, unadjusted p-value <0.01) . Inflammatory markers significantly improved: hs-CRP from 7.8 nmol/L to 4.4 nmol/L (-43.6%) , white blood cell count from 7.2 k/mm3 to 6.4 k/mm3 (-11.1%) . At all time points, liver markers have been in the normal range. There were no changes in renal biomarkers. eGFR was stable at CKD2. Subcohort completers’ analysis of those with eGFR<60 ml/min/1.73m2 (n=10) showed an increase from 47.8 to 57.1 ml/min/1.73m2 (p=0.01). Six of the subjects (60%) with BL CKD3 who completed 5y rose to CKD2. Of the 107 subjects with BL CKD2, 7 (6.5%) progressed to CKD3. Conclusions: People with T2D following VLCI for 5y show improvements in diabetic dyslipidemia and inflammation. Notably, there is no change in LDLc. There is no significant deterioration in liver and renal labs, although regression from CKD3 to 2 is possible with a VLCI and warrants further investigation. Disclosure C.G.Roberts: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.Phinney: Employee; Virta Health Corp. S.Hallberg: Advisory Panel; Atkins Nutritionals Inc., Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.J.Athinarayanan: Employee; Virta Health Corp. M.Vantieghem: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. A.L.Mckenzie: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. B.M.Volk: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.N.Adams: Employee; Virta Health Corp. B.Fell: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.E.Ratner: Employee; Virta Health Corp. J.Volek: Advisory Panel; Abbott Diagnostics, Simply Good Foods, Stock/Shareholder; Virta Health Corp.