While this trial is in the beginning stages, it has indicated that profound changes are possible without
harming the patients. It will be very interesting to read what the
results are at the end of the trial.
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
has long been viewed (by the medical profession) as a chronic
condition that can be managed but is inevitably progressive.
While clinicians may be increasingly
more aware that type 2 diabetes 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 type 2 diabetes: from management to
reversal without the use of surgery (bold is my emphasis).
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 type 2 diabetes were enrolled in the Virta
Clinic. 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 type 2
diabetes by non-surgical means is relatively new, but is gaining
attention in both the scientific literature and popular press. So,
what does reversal of type 2 diabetes 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 type 2 diabetes.
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.
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
- 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 type 2 diabetes 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
type 2 diabetes 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.
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