Abstract
Purpose: 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.Materials 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. 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.Results: 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 p < 0.00012.Conclusion: 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.Clinical Trial Registration: Clinicaltrials.gov NCT02519309
Highlights
Type 2 diabetes (T2D), obesity, and metabolic disease impact over one billion people and present a challenge to public health and economic growth [1, 2]
Reductions from baseline to 2 years in the continuous care intervention (CCI) group resulting from intent-to-treat analyses included: hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, weight, systolic blood pressure, diastolic blood pressure, triglycerides, and liver alanine transaminase, and high density lipoprotein (HDL)-C increased
Three non-pharmaceutical approaches have demonstrated high rates of at least temporary T2D diabetes reversal or remission: bariatric surgery, very low calorie diets (VLCD), and nutritional ketosis achieved through carbohydrate restriction [8,9,10]
Summary
Type 2 diabetes (T2D), obesity, and metabolic disease impact over one billion people and present a challenge to public health and economic growth [1, 2]. When lifestyle interventions are insufficient, medications are indicated to manage the disease and slow progression [6, 7]. When T2D care directed at disease reversal is successful, this includes achievement of restored metabolic health, glycemic control with reduced dependence on medication, and in some cases disease remission. Three non-pharmaceutical approaches have demonstrated high rates of at least temporary T2D diabetes reversal or remission: bariatric surgery, very low calorie diets (VLCD), and nutritional ketosis achieved through carbohydrate restriction [8,9,10]. Each approach has demonstrated improved glycemic control and CVD risk factors, reduced pharmaceutical dependence, and weight loss. The three approaches show a similar time-course with glycemic control preceding weight loss by weeks or months, suggesting potential overlap of mechanisms [11, 12]
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