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

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

<p>Diet, Diabetes Status, and Personal Experiences of Individuals with Type 2 diabetes Who Self-Selected and Followed a Low Carbohydrate High Fat diet</p>

“…5 That LCHF diets have the potential to put T2D into remission is becoming increasingly recognized, especially in trials with a high level of patient monitoring and support. 3,8 The 7 participants from the current study who started their LCHF diet soon after diagnosis responded particularly well, which agrees with the notion that an LCHF diet may be especially effective for remission in newly diagnosed T2D patients or those taking less medication. 3,14 The selection of highly motivated participants may explain why our findings are considerably more favorable than conclusions from a number of recent metaanalyses of RCTs.…”

“…7 More recently, severe carbohydrate restriction has also gained attention due to the potential for T2D remission. 3,8,9 There has been much scientific interest in carbohydrate restricted diets to manage T2D, with at least 22 randomized control trials, 10 non-randomized control trials, and 10 systematic reviews (9 with meta-analyses) that have investigated the effects of carbohydrate restriction on glycemic control in patients with T2D. 10−13 While there is considerable heterogeneity in findings, this evidence generally shows that the lower carbohydrate dietary interventions are at least as effective as control diets for improving HbA1c, T2D medication requirements, body weight, and dyslipidemia.…”

A Short-Term Ketogenic Diet Impairs Markers of Bone Health in Response to Exercise

“…The current study identifies further complexity in the interaction between the ketogenic diet and exercise with respect to markers of bone modeling/remodeling, in which catabolic processes are augmented and anabolic processes are reduced. The LCHF diet is also popular within the general community for its purported health benefits, including rapid weight loss and improved glycemic control (22). However, data from animal studies (12,13) demonstrate that chronic LCHF diets are associated with impaired bone growth, reduced bone mineral content, compromised mechanical properties, and slower fracture healing.…”

“…Furthermore, increased bone loss has been reported in children with intractable epilepsy placed on a medically supervised LCHF diet for 6 months (14,15). In contrast, adults with type 2 diabetes mellitus who self-selected to consume a LCHF diet for 2 years experienced no changes in spinal BMD in comparison to a "usual care" group (22). One explanation for these divergent outcomes involves interactions of the LCHF diet with the level of habitual contractile activity.…”

A Standard Lipid Panel Is Insufficient for the Care of a Patient on a High-Fat, Low-Carbohydrate Ketogenic Diet

“…Ketogenic diets are high-fat, low-carbohydrate diets that induce the liver to generate ketone bodies, particularly the ketone body β-hydroxybutyrate, a metabolic energy source and signaling molecule evolutionarily designed to efficiently fuel the brain and body during times of carbohydrate scarcity. Although clinical studies implementing ketogenic diets have heretofore been difficult to conduct, and more research is still needed, a body of data demonstrates that ketogenic diets may be useful in the treatment of a wide range of chronic diseases that share inflammation as a common underlying pathology (1)(2)(3)(4)(5)(6)(7). One of these diseases is ulcerative colitis, an inflammatory bowel disease.…”