RT Journal Article
SR Electronic
T1 Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-year Non-randomized Clinical Trial
JF bioRxiv
FD Cold Spring Harbor Laboratory
SP 476275
DO 10.1101/476275
A1 Athinarayanan, Shaminie J.
A1 Adams, Rebecca N.
A1 Hallberg, Sarah J.
A1 McKenzie, Amy L.
A1 Bhanpuri, Nasir H.
A1 Campbell, Wayne W.
A1 Volek, Jeff S.
A1 Phinney, Stephen D.
A1 McCarter, James P.
YR 2018
UL http://biorxiv.org/content/early/2018/12/06/476275.abstract
AB OBJECTIVE Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We aim to assess the effects of a continuous care intervention (CCI) on retention, glycemic control, weight, body composition, cardiovascular, liver, kidney, thyroid, inflammatory markers, diabetes medication usage and disease outcomes at 2 years in adults with type 2 diabetes (T2D).RESEARCH DESIGN AND METHODS An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively.RESULTS Significant changes from baseline to 2 years in the CCI group included: HbA1c (−12% from 7.7±0.1%); fasting glucose (−18% from 163.67±3.90 mg/dL); fasting insulin (−42% from 27.73±1.26 pmol L-1); weight (−10% from 114.56±0.60 kg); systolic blood pressure (−4% from 131.7±0.9 mmHg); diastolic blood pressure (−4% from 81.8±0.5 mmHg); triglycerides (−22% from 197.2±9.1 mg/dL); HDL-C (+19% from 41.8±0.9 mg/dL), and liver alanine transaminase (−21% from 29.16±0.97 U/L). Spine bone mineral density in the CCI group was unchanged. Glycemic control medication use (excluding metformin) among CCI participants declined (from 56.9% to 26.8%, P=1.3×10-11) including prescribed insulin (−62%) and sulfonylureas (−100%). The UC group had no significant changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also significant resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had p-values <0.00012.CONCLUSIONS The CCI sustained long-term beneficial effects on multiple clinical markers of diabetes and cardiometabolic health at 2 years while utilizing less medication. The intervention was also effective in the resolution of diabetes and visceral obesity, with no adverse effect on bone health.TRIAL REGISTRATION Clinicaltrials.gov NCT02519309Author contributionsS.J.A, R.N.A, and J.P.M drafted the manuscript. S.J.A, R.N.A, A.L.M, N.H.B, and S.J.H participated in data acquisition and compiling. R.N.A and S.J.A analyzed the data. J.P.M, A.L.M, N.H.B, W.W.C, R.N.A, S.J.A, S.J.H, S.D.P and J.S.V edited the manuscript. All authors approved the final version of the manuscript.AbbreviationsCCIcontinuous care intervention;UCusual care;T2Dtype 2 diabetes;HbA1chemoglobin A1c;CVDcardiovascular disease;VLCDvery low calorie diet;BMIbody mass index;BHBbeta-hydroxybutryrate;BMDbone mineral density;CAFcentral abdominal fat;A/Gandroid:gynoid ratio;LELMlower extremities lean mass;HDLhigh density lipoprotein;LDLlow density lipoprotein;ALTalanine aminotransferase;ASTaspartate aminotransferase;ALPalkaline phosphatase;NAFLDnonalcoholic fatty liver disease;NLFNAFLD liver fat score;NFSNAFLD fibrosis score;TSHthyroid stimulating hormone;BUNblood urea nitrogen;eGFRestimated glomerular filtration rate;hsCRPhigh sensitive C-reactive protein;WBCwhite blood cells;HOMA-IRHomeostatic Model Assessment of Insulin Resistance;SGLT-2sodium-glucose cotransporter-2 inhibitors;DPP-4dipeptidyl peptidase-4 inhibitors;GLP-1glucagon-like-peptide 1 receptor agonists;FFMfat-free mass;VATvisceral adipose tissue;GLMgeneralized linear model;LMMlinear mixed-effect model;ADAAmerican Diabetes Association;CLIAClinical Laboratory Improvement Amendments;IRBInstitutional Review Board;DXAdual-energy X-ray absorptiometry