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

• Published in: Frontiers in endocrinology (Lausanne) Vol. 10; p. 348
• Main Authors: Athinarayanan, Shaminie J, Adams, Rebecca N, Hallberg, Sarah J, McKenzie, Amy L, Bhanpuri, Nasir H, Campbell, Wayne W, Volek, Jeff S, Phinney, Stephen D, McCarter, James P
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 05.06.2019
• Subjects: body composition; Endocrinology; HbA1c; nutritional ketosis; reversal and remission; type 2 diabetes; nutritional ketosis; body composition; type 2 diabetes; HbA1c; reversal and remission
• ISSN: 1664-2392; 1664-2392
• DOI: 10.3389/fendo.2019.00348

Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. We previously reported the effectiveness of a novel digitally-monitored continuous care intervention (CCI) including nutritional ketosis in improving weight, glycemic outcomes, lipid, and liver marker changes at 1 year. Here, we assess the effects of the CCI at 2 years. 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. Primary outcomes were retention, glycemic control, and weight changes at 2 years. Secondary outcomes included changes in body composition, liver, cardiovascular, kidney, thyroid and inflammatory markers, diabetes medication use and disease status. Reductions from baseline to 2 years in the CCI group resulting from intent-to-treat analyses included: HbA1c, fasting glucose, fasting insulin, weight, systolic blood pressure, diastolic blood pressure, triglycerides, and liver alanine transaminase, and HDL-C increased. Spine bone mineral density in the CCI group was unchanged. Use of any glycemic control medication (excluding metformin) among CCI participants declined (from 55.7 to 26.8%) including insulin (-62%) and sulfonylureas (-100%). The UC group had no changes in these parameters (except uric acid and anion gap) or diabetes medication use. There was also resolution of diabetes (reversal, 53.5%; remission, 17.6%) in the CCI group but not in UC. All the reported improvements had < 0.00012. The CCI group 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. Clinicaltrials.gov NCT02519309.