Linking To And Excerpting From Diabetes Research And Clinical Practice’s “5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study”

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5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study [PubMed Abstract] [Full-Text HTML] [Full-Text PDF] Diabetes Res Clin Pract. 2024 Nov:217:111898. doi: 10.1016/j.diabres.2024.111898. Epub 2024 Oct 20.

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Abstract

Aims: This study assessed the five-year effects of a continuous care intervention (CCI) delivered via telemedicine, counseling people with type 2 diabetes (T2D) on a very low carbohydrate diet with nutritional ketosis.

Methods: Participants with T2D were enrolled in a 2-year, open-label, non-randomized study comparing CCI and usual care (UC). After 2 years, 194 of the 262 CCI participants were approached for a three-year extension. Of these, 169 consented, and 122 remained in the study for five years. Primary outcomes were changes in diabetes status assessed using McNemars’ test, including remission and HbA1c < 6.5 % on no glucose lowering medication or only on metformin at 5 years. Changes in body mass, glycemia, and cardiometabolic markers from baseline to 5 years were assessed using linear mixed-effects models.

Results: Twenty percent (n = 24) of the five-year completers achieved remission, with sustained remission observed over three years in 15.8 % (n = 19) and four years in 12.5 % (n = 15). Reversal to HbA1c < 6.5 % without medication or only metformin was seen in 32.5 % (n = 39). Sustained improvements were noted in body mass (-7.6 %), HbA1c (-0.3 %), triglycerides (-18.4 %), HDL-C (+17.4 %), and inflammatory markers, with no significant changes in LDL-C and total cholesterol.

Conclusions: Over five years, the very low carbohydrate intervention showed excellent retention and significant health benefits, including diabetes remission, weight loss, and improved cardiometabolic markers.

Keywords: Cardiometabolic; Diabetes remission; Nutritional ketosis; Telemedicine.

Keywords

  1. Nutritional ketosis
  2. Diabetes remission
  3. Cardiometabolic
  4. Telemedicine

1 Introduction

Although type 2 diabetes (T2D) has historically been considered a chronic and progressive disease, evidence for therapies enabling reversal of the condition — that is, therapies which lower HbA1c and enable deprescription of antihyperglycemic medications, even to the point of sustained, drug-free remission — has grown in the last two decades. Consensus statements reflect these therapeutic advancements. Buse et al., first defined diabetes remission in 2009 , and an international consensus of professional societies further refined the definition in 2021 to refer to a HbA1c below that diagnostic of diabetes (<6.5 %) for at least three months in the absence of glucose-lowering medication . Given the association between hyperglycemia and increased risk of diabetes complications , it is plausible that achievement of diabetes remission confers significant long term health benefits and is an appropriate therapeutic target.
Several approaches have been reported to elicit T2D remission including surgery, intensive insulin therapy upon diagnosis, and nutrition therapy utilizing significant caloric and/or dietary carbohydrate restriction . Evidence of T2D remission beyond two years is sparse, with examples in bariatric surgery and following the three lifestyle interventions: 1) meal replacements for caloric restriction and physical activity ; 2) short-term total diet replacement with rescue therapy for weight maintenance ; and 3) a calorie-restricted Mediterranean diet . It is well recognized among professional society guidelines that carbohydrate restricted nutrition therapy results in improved glycemia, most cardiovascular risk markers and reduced need for medication , yet current evidence is limited to two-years of follow-up .
We previously reported improvements in glycemia, body weight, markers of liver disease and cardiovascular risk over two years among participants with T2D receiving a continuous care intervention (CCI) delivered via telemedicine by a care team who counseled participants on a very low carbohydrate diet including nutritional ketosis . Sustained improvements over two years were observed with high (74 %) retention, of whom 19 % achieved remission by the definition of Buse et al.  and 25 % according to the Riddle et al. 2021 international consensus definition . Upon completion of the two-year study, participants in the CCI were offered participation in a three-year extension study to assess the five-year effects of the intervention. The objective of this study was to evaluate the long-term maintenance of the change in diabetes status, glycemia, medications, weight, and markers of cardiometabolic health over a five-year period among participants who consented to the extension study.

 

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