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Founded on decades of research and supported by ongoing clinical studies

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Clinical Outcomes

Peer-reviewed research evaluating the effect of the Virta Treatment demonstrates that patients can safely improve health outcomes associated with type 2 diabetes, obesity, atherogenic dyslipidemia, hypertension, and inflammation.

By impacting these chronic conditions, the Virta Treatment improves several risk factors for type 2 diabetes and cardiovascular disease.

Type 2 Diabetes

While reducing and eliminating glycemic control medications, Virta patients lowered HbA1c by 1.3% on average after one year and improved insulin resistance measured by HOMA-IR. 60% of patients enrolled one year attained an HbA1c below 6.5% without the use of diabetes medications other than metformin.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Type 2 diabetes medications

Obesity

Excess weight represents risk for both type 2 diabetes and cardiovascular disease. Virta patients sustained the loss of 12% of their body weight over the year. The prevalence of class III obesity among participants was reduced from 46% to 20%.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar chart showing comparison of Virta to Usual Care: Weight loss

Atherogenic Dyslipidemia

Characterized by high triglycerides and low HDL-C, atherogenic dyslipidemia is common among patients with insulin resistance and represents increased cardiovascular risk. Virta patients improved both markers, with the TG/HDL-C ratio declining from 4.7 to 3 on average.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Atherogenic Dyslipidemia

Hypertension

Elevated blood pressure, especially in the presence of additional risk factors, increases cardiovascular risk. Virta patients reduced blood pressure and the need for antihypertensive medication, especially diuretics.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Hypertension

Inflammation

Inflammation is a common underlying factor in obesity, insulin resistance, hypertension, and cardiovascular disease. C-reactive protein and white blood cell count, common markers of inflammation, were significantly reduced in Virta patients with type 2 diabetes.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Inflammation

Safety

A common concern in the treatment of type 2 diabetes is hypoglycemia. In our clinical trial, no hypoglycemic events requiring assistance were reported. Additionally, treatment at Virta resulted in neutral or positive effects on markers of kidney and liver function.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Safety measures

Cardiovascular Risk Markers

10-year ASCVD risk score improves after one year of the Virta Treatment. Most lipid and lipoprotein risk markers improved or were unaffected; an undesirable change was observed in one marker.
Chart legend, showing Virta (blue) and Usual Care (gray)Bar charts showing comparison of Virta to Usual Care: Cardiovascular risk markers
Outcomes above were reported in Hallberg SJ et al. Diabetes Therapy. 2018;9(2):583-612 and Bhanpuri NH et al. Cardiovasc Diabetol. 2018; 17:56.

Advancing science and medicine

Virta Health Research is committed to improving patient health outcomes by advancing the understanding of chronic metabolic conditions and how to best treat them, while providing evidence to inform clinicians and patients in their care decisions.

Peer-reviewed papers

Cover of an academic paper: 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

Long-term, sustainable benefit to key diabetes outcomes

At two years of treatment, Virta trial patients still experienced clinically significant improvements in HbA1c %, metabolic syndrome rate, and markers of inflammation. More than half of trial completers met the criteria for diabetes reversal, and a significant portion of those individuals also had partial and complete diabetes remission. Along with these improvements in health outcomes, 67% of diabetes-specific prescriptions were discontinued, and 91% of patients who began on insulin either reduced or eliminated their insulin dosage.
Athinarayanan SJ, Adams RN, Hallberg SJ, et al. 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. Frontiers in Endocrinology. 2019; 10:348. doi: 10.3389/fendo.2019.00348
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Cover of an academic paper: Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at One Year: An Open Label, Non-Randomized, Controlled Study

Continued improvement in health outcomes at 1 year

After one year of treatment, patients who chose Virta improved glycemic control and markers of other chronic conditions. 94% of patients on insulin reduced or eliminated their dosage. Average weight loss was 12%. Other improvements included markers of cardiovascular disease, inflammation, and liver function.
Hallberg SJ, McKenzie AL, Williams P, et al. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at One Year: An Open Label, Non-Randomized, Controlled Study. Diabetes Therapy. 2018; 9(2): 583-612. doi: 10.1007/s13300-018-0373-9
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Cover of an academic paper: A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes

Rapid impact on type 2 diabetes

The first investigation of Virta’s novel care model demonstrated that patients could rapidly improve glycemic control through reductions in fasting blood glucose, HbA1c, and medication use after 10 weeks of treatment. Patients lost 7% of their body weight on average and reported less hunger.
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.
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Long-term prediabetes reversal and type 2 diabetes prevention

Virta studied the effects of its intervention in patients with prediabetes and found that only 3% of trial participants progressed to type 2 diabetes over a two year period. Over half of participants achieved normoglycemia, with 75% of patients retained at the two-year mark.
McKenzie AL, Athinarayanan SJ, McCue JJ, Adams RN, Keyes M, McCarter JP, Volek JS, Phinney SD, Hallberg SJ. Type 2 Diabetes Prevention Focused on Normalization of Glycemia: A Two-Year Pilot Study. Nutrients. 2021; 13(3):749. https://doi.org/10.3390/nu13030749
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Cover of an academic paper: Impact of a 2-year trial of nutritional ketosis on indices of cardiovascular disease risk in patients with type 2 diabetes

Long-term improvement in cardiovascular risk factors

Virta examined markers of cardiovascular disease at two-years and found that patients living with type 2 diabetes sustained improvements in multiple cardiovascular risk factors. This includes long-term improvement in traditional markers of atherogenic dyslipidemia (triglycerides and HDL cholesterol) and a substantial reduction in pro-atherogenic small LDL particles.
Athinarayanan, S.J., Hallberg, S.J., McKenzie, A.L. et al. Impact of a 2-year trial of nutritional ketosis on indices of cardiovascular disease risk in patients with type 2 diabetes. Cardiovasc Diabetol 19, 208 (2020). https://doi.org/10.1186/s12933-020-01178-2
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Cover of an academic paper: Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis at One Year: An Open Label, Non-Randomized, Controlled Study

Significant impact on cardiovascular risk factors

For patients living with type 2 diabetes, the risk of cardiovascular disease (CVD) is higher than average and CVD is the leading cause of mortality. There is a need for interventions that mitigate cardiovascular risk in addition to improving glycemic control and markers of insulin resistance. On average, the Virta Treatment improved or had no effect on most markers of cardiovascular risk. For the subset of individuals whose key markers did not improve, the range of responses were similar to those observed in participants who pursued the usual care for their type 2 diabetes.
Bhanpuri NH, Hallberg SJ, Williams PT, McKenzie AL, Ballard KD, Campbell WW, McCarter JP, Phinney SD, Volek JS. Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis at One Year: An Open Label, Non-Randomized, Controlled Study. Cardiovasc Diabetol. 2018; 17:56. doi:10.1186/s12933-018-0698-8
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Sustained improvement in depressive symptoms at 2 years

Virta patients experienced rapid and sustained improvement in depressive symptoms, with nearly one-third fewer patients meeting the clinical cutoff for depression at two years. Depressed patients followed a similar pattern of metabolic health improvement compared to those without a past diagnosis.
Adams RN, Athinarayanan SJ, McKenzie AL, Hallberg SJ, McCarter JP, Phinney SD, Gonzalez JS. Depressive symptoms improve over 2 years of type 2 diabetes treatment via a digital continuous remote care intervention focused on carbohydrate restriction. J Behav Med. 2022 doi.org/10.1007/s10865-021-00272-4
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Cover of an academic paper: Post hoc analyses of surrogate markers of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis in patients with type 2 diabetes in a digitally supported continuous care intervention: an open-label, non-randomised controlled study

Evidence of non-alcoholic fatty liver disease improvement

An estimated 60% of American adults living with type 2 diabetes have non-alcoholic fatty liver disease (NAFLD), and the only treatment currently endorsed by professional guidelines for NAFLD is weight loss. At one year, almost 80% of patients with type 2 diabetes who participated in the Virta treatment lost more than 5% of their starting body weight, which is associated with improvement in steatosis. Concurrent with 12% average weight loss, liver enzyme concentrations, surrogate scores for liver steatosis and fibrosis, and inflammation improved in these patients.
Vilar-Gomez E, Athinarayanan SJ, Adams RN, et al Post hoc analyses of surrogate markers of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis in patients with type 2 diabetes in a digitally supported continuous care intervention: an open-label, non-randomised controlled study BMJ Open 2019;9:e023597. doi: 10.1136/bmjopen-2018-023597
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Long-term improvement in knee pain and function

Osteoarthritis (OA) is a painful and debilitating condition affecting more than 54 million U.S. adults (nearly 23%) annually. Among adults with diabetes, the prevalence of OA increases to an estimated 48.1%. Virta patients with type 2 diabetes, however, experienced significant long-term improvement in knee pain and function from baseline to two years.
Lyman, K.S., Athinarayanan, S.J., McKenzie, A.L. et al. Continuous care intervention with carbohydrate restriction improves physical function of the knees among patients with type 2 diabetes: a non-randomized study. BMC Musculoskelet Disord 23, 297 (2022). https://doi.org/10.1186/s12891-022-05258-0
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Research Initiatives

IUH Clinical Trial

In collaboration with researchers and clinicians at IU Health Arnett, the primary purpose of this clinical trial was to demonstrate the therapeutic effects of the intervention over 2 years in participants with type 2 diabetes, prediabetes, and metabolic syndrome.

Secondary purposes included assessing for differences in therapeutic effects of the intervention between patients who self-select onsite vs. web-based education delivery, exploring relationships between change in LDL cholesterol and carotid intima media thickness, and evaluating the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.

The trial began in 2015 and concluded in 2021.
Learn more about the IUH Clinical Trial
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Virta Health Registry for Remote Care of Chronic Conditions

The purpose of this registry is to establish a research data repository, comprised primarily of data generated in the course of clinical care, to conduct research on Virta Health clinical interventions and the chronic conditions present in Virta Health patients.
Learn more about the Virta Health Registry
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White Papers

White paper cover: "Clinical Trial Update: 6 month outcomes in patients with type 2 diabetes"

6-month Clinical Trial Outcomes

Virta aims to address the challenges of sustaining lifestyle and nutritional medicine interventions with ongoing support from a health coach and a medical provider to continuously personalize their care. In this white paper, we discuss participant retention and health outcomes achieved by participants with type 2 diabetes after six months.
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White paper cover: "The Cardiovascular Benefits of the Virta Treatment"

The Cardiovascular Benefits of the Virta Treatment

Cardiovascular disease is the number one cause of morbidity and mortality in patients with type 2 diabetes. Here we discuss the impact of the Virta Treatment on risk factors for cardiovascular disease including hypertension, atherogenic dyslipidemia, LDL partitioning, inflammation, insulin resistance, obesity, liver function, carotid intima media thickness, medications, and composite risk scores. Together these findings suggest near-term and projected long-term improvement in cardiovascular risk.
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Science and research blog

Visit the Virta Health blog to learn more about our thoughts on the latest research and hot topics in the field.

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