Results from the first 70 days of the Virta Clinic trial suggest the historic dietary approach to management of type 2 diabetes has been all wrong.
Type 2 diabetes (T2D) has long been viewed as a chronic condition that can be managed but is inevitably progressive.1 While clinicians may be increasingly more aware that T2D can be reversed, most think it is only possible through drastic means like bariatric surgery. With the recent findings from our ongoing clinical trial, which add to the existing literature, medicine may be on the cusp of a major paradigm shift for the treatment of T2D: from management to reversal without the use of surgery.
The published results highlight the first 70 days of an ongoing 2-year clinical trial collaboration between Virta Health and Indiana University Health, in which 262 patients with T2D were enrolled in the Virta Clinic.2 The clinic combines online education for behavior change, biometric feedback, peer support and an individualized nutritional approach that promotes nutritional ketosis. After 70 days and greater than 90% retention, mean weight loss was 7.2% and the mean glycated hemoglobin (A1C) reduction was 1%, with 56% of patients achieving an A1C below 6.5%.
It is extremely important to note that this reduction in A1C was achieved while medications were reduced. At baseline, 89% of the patients were taking one or more diabetes medications, and at 70 days 58% of patients had either reduced or completely eliminated their medications. This is unlike treatment strategies aimed to lower A1C in the past. For example, in the ACCORD trial,3, where A1C levels were lowered with aggressive medication use, the most aggressively treated patients had worse outcomes. Specifically, the intensive glycemic control group who were prescribed more medications, which often included insulin with multiple oral agents, had significantly more weight gain, more episodes of severe hypoglycemia, and greater mortality than the standard group.
Many were led to conclude from the ACCORD trial that strictly lowering glucose may actually be detrimental. However, it may be that how glucose is lowered is a critical consideration. In the Virta 70-day trial, there were no serious adverse events and no episodes of serious symptomatic hypoglycemic events requiring medical intervention.
The concept of reversing T2D by non-surgical means is relatively new, but is gaining attention in both the scientific literature and popular press.4,5 So, what does reversal of T2D actually mean? It means that patients who previously were on medications to control elevated blood glucose now maintain blood glucose below the diabetes threshold despite reducing or eliminating the need for hypoglycemic medications. This is exactly the opposite of what was thought to be the inescapable progression of a disease that puts patients at high risk for so many complications, including cardiovascular disease, blindness, renal failure, and amputations.
A major reason that the concept of management to slow progression of T2D has prevailed for so long is the standard nutritional recommendations, which focus dietary macronutrient intake on carbohydrate. Basic physiology dictates that carbohydrate ingestion causes blood glucose to rise, particularly in the face of the insulin resistance that underlies T2D. In fact, the most recent edition of the Nutrition Therapy Recommendations for the Management of Adults With Diabetes6 from the American Diabetes Association states that “total amount of carbohydrate eaten is the primary predictor of glycemic response.” This makes basic science sense, and the practical response would be to decrease dietary carbohydrates if the goal is to decrease blood glucose. This approach has been shown to be effective in improving glycemic control while reducing or eliminating medications in prior smaller studies.7-9
In addition to adjusting dietary carbohydrate to each patient’s level of insulin resistance, patients need individualized support and medical management.The Virta Clinic specializes in being able to provide the personalized treatment needed on a personalized schedule. While barriers exist to convenient and accessible care in a brick-and-mortar clinic, the Virta Clinic is able to overcome these by providing a full medical specialty clinic online. Each patient receives a health coach who guides patients through appropriate nutrition changes while considering lifestyle, cultural, and financial barriers. Specialty-trained physician supervision for each patient ensures that medications are decreased safely and efficiently
Ultimately, our current trial will add to the compelling evidence that:
1. Diabetes can be reversed while reducing medication and without risk, cost, or side effects of bariatric surgery and
2. Reversal can happen in a large percentage of patients, not only in outliers.
At the very least, our results beg the question: has the medical profession been approaching the dietary management in T2D all wrong? I firmly believe the dialogue has to change to let patients know that reversal is possible. By not doing so, we are complicit in the continued staggering rise of this disease.
With the increasing cost of health care, including $1 of every $3 in Medicare going to the treatment of T2D and its comorbidities, we have to look for solutions. In doing so, we must be willing to acknowledge that there have been past shortcomings in both dietary recommendations and treatment goals. Our patients deserve the opportunity to gain control of their health. They want more than just another prescription or procedure. To help them, we need to change the dialogue. We need to talk about reversal and provide the knowledge and support to achieve it.
1. UK Prospective Diabetes Study (UKPDS) Group. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33 Lancet. 1998;352(9131):837-853.
2. McKenzie AL, Hallberg SJ, Creighton BC, et al. A Novel intervention including individualized nutritional recommendations reduces hemoglobin A1C level, medication use, and weight in type 2 diabetes. JMIR Diabetes 2017;2(1):e5. DOI: 10.2196/diabetes.6981.
3. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes N Engl J Med 2008;358:2545-2559. DOI: 10.1056/NEJMoa0802743.
4. Hallberg S, Hamdy O. Before you spend $26,000 on weight loss surgery, do this. The New York Times. https://www.nytimes.com/2016/09/11/opinion/sunday/before-you-spend-26000-on-weight-loss-surgery-do-this.html. Published September 10, 2016. Accessed April 10, 2017.
5. Gow ML, Baur LA, Johnson NA. et al. Reversal of type 2 diabetes in youth who adhere to a very-low-energy diet: a pilot study. Diabetologia. 2017;60:406. doi:10.1007/s00125-016-4163-5.
6. Evert AB, Boucher JL, Cypress M, et al. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care 2014; 37 suppl 1:S120-S143. DOI: 10.2337/dc14-S120.
7. Boden G, Sargrad K, Homko C, Mozzoli M, Stein TP. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005;142:403-411. doi: 10.7326/0003-4819-142-6-200503150-00006.
8. Saslow LR, Kim S, Daubenmier JJ, et al. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLoS ONE. 2014;9(4):e91027. doi:10.1371/journal.pone.0091027.
9. Westman EC, Yancy WS, Mavropoulos JC, Marquart M, McDuffie JR. The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus. Nutr Metab. 2008;5:36. doi: 10.1186/1743-7075-5-36.