RT Journal Article SR Electronic T1 Improvement in Patient-Reported Sleep in Type 2 Diabetes and Prediabetes Participants Receiving a Continuous Care Intervention with Nutritional Ketosis JF bioRxiv FD Cold Spring Harbor Laboratory SP 389841 DO 10.1101/389841 A1 Morgan J. Siegmann A1 Shaminie J Athinarayanan A1 Sarah J Hallberg A1 Amy L. McKenzie A1 Nasir H. Bhanpuri A1 Wayne W. Campbell A1 James P. McCarter A1 Stephen D. Phinney A1 Jeff S. Volek A1 Christa J. Van Dort YR 2018 UL http://biorxiv.org/content/early/2018/08/13/389841.abstract AB Objective Sleep disruption is frequently associated with type 2 diabetes (T2D) and hyperglycemia. We recently reported the effectiveness of a continuous care intervention (CCI) emphasizing nutritional ketosis for improving HbA1c, body weight and cardiovascular risk factors in T2D patients. The present study assessed the effect of this CCI approach on sleep quality using a subjective patient-reported sleep questionnaire.Methods A non-randomized, controlled longitudinal study; 262 T2D and 116 prediabetes patients enrolled in the CCI and 87 separately recruited T2D patients continued usual care (UC) treatment. Patients completed the Pittsburgh Sleep Quality Index (PSQI) questionnaire. A PSQI score of >5 (scale 0 to 21) was used to identify poor sleepers.Results Global sleep quality improved in the CCI T2D (p<0.001) and prediabetes (p<0.001) patients after one year of intervention. Subjective sleep quality (component 1), sleep disturbance (component 5) and daytime dysfunction (component 7), also showed improvements in the CCI T2D (p<0.01 for sleep quality and sleep disturbance; and p<0.001 for daytime dysfunction) and prediabetes patients (p<0.001 for all three components); compared to the UC T2D group after one year. The proportion of patients with poor sleep quality was significantly reduced after one year of CCI (T2D; from 68.3% at baseline to 56.5% at one year, p=0.001 and prediabetes; from 77.9% at baseline to 48.7% at one year, p<0.001).Conclusion This study demonstrates improved sleep quality as assessed by PSQI in patients with T2D and prediabetes undergoing CCI including nutritional ketosis but not in T2D patients receiving UC. The dietary intervention benefited both sleep quality and the severity of T2D symptoms suggesting that nutritional ketosis improves overall health via multiple mechanisms.Author contributionsS.J.A, M.S, C.J.V and J.P.M drafted the manuscript. A.L.M, N.H.B, S.J.H and S.J.A participated in data acquisition and compiling. M.S and S.J.A analyzed the data. C.J.V supervised this particular analysis, J.P.M, A.L.M, S.J.H, N.H.B, W.W.C, S.D.P and J.S.D edited the manuscript. W.W.C. proposed measuring subjective sleep quality as part of the parent Continuous Care Intervention clinical trial. All authors approved the final version of the manuscript.AbbreviationsCCIcontinuous care interventionUCusual careT2Dtype 2 diabetesBMIbody mass idexPSQIPittsburgh Sleep Quality IndexOSAobstructive sleep apneaHbA1chemoglobin A1cCPAPcontinuous positive airway pressureAHIapnea and hypopnea indicesKDketogenic dietREMrapid eye movementSWSslow wave sleepBHBbeta-hydroxybutryrateHOMA-IRhomeostatic model assessment of insulin resistancehsCRPhigh-sensitivity C-reactive protein