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Low Carb Diet, Biomarker Tracking Help Reverse Diabetes

Clinical trial key findings

Key findings from type 2 diabetes clinical trial (Purdue Research Foundation)

8 February 2018. A combination of low-carbohydrate diet, with close monitoring of health indicators and coaching via a mobile app are shown in a clinical trial to reverse type 2 diabetes, including reductions in medication and insulin therapy. A description of the program offered by Virta Health Inc. and results after 1 year of the trial appear in yesterday’s issue of the journal Diabetes Therapy.

Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, beta cells in the pancreas produce some but not enough insulin, or the body cannot process insulin. According to the International Diabetes Federation, diabetes affects an estimated 425 million people worldwide.

Virta Health, based in San Francisco, offers a program of a diet low in carbohydrates with moderate protein intake that the company says reduces resistance to insulin that in many cases is the main driver of type 2 diabetes. Reducing starchy carbohydrates, says Virta, promotes nutritional ketosis, a condition where ketone bodies in the blood draw energy from fat cells rather than carbohydrates, and in the process reduce the oxidative stress and inflammation that trigger insulin resistance.

While this kind of a diet can help reduce the biological triggers behind type 2 diabetes, says the company, maintaining the regimen for an extended period can be difficult for many individuals, without close monitoring and feedback. The second part of Virta’s program provides individualized coaching and medical supervision, where patients track their key biomarkers and other health indicators, such as blood glucose and ketone levels, body weight, and medication use. These data are captured with a mobile app, where coaching and medical advice are provided remotely to individuals in the program. In addition, program participants receive social support in an online community.

Virta Health is testing the program in a 5-year clinical trial, with results from the study’s first year reported in the new paper. The trial recruited 349 adults with type 2 diabetes at Indiana University Health in Lafayette, also affiliated with Purdue University, led by diabetes specialist Sarah Hallberg, now an employee of Virta Health. Of the participants, 262 individuals enrolled in the Virta Health program, while 87 participants received the usual care for type 2 diabetes, consisting of regular primary care or endocrinologist visits, counseling by dieticians, and standard diabetes education.

The results show after 1 year Virta program participants exhibit fewer signs of type 2 diabetes than their counterparts receiving the usual care. Participants in the Virta program record 1.3 percent lower blood glucose levels (HbAic), while among the standard care participants HbA1c rose 0.2 percent. Virta participants likewise reduced their body weight by 12 percent, while the usual care group on average remained the same weight. Also, an indicator of insulin resistance, known as HOMA-IR, fell 55 percent among Virta participants, while rising 16 percent in the standard care group.

In addition, nearly all Virta participants (94%) were able to reduce or discontinue their insulin intake after 1 year, including 40 percent who stopped taking insulin completely, while use of diabetes drugs other than metforin dropped by nearly half (48%). Each group of participants reported 6 adverse events during the clinical trial, with no adverse effects among Virta participants related to the program.

“Due to the unique structure of the trial and use of telemedicine,” says Hallberg in a Purdue statement, “we helped prevent any significant hypoglycemic events. Instead of patients scheduling an office visit, they could log their blood sugar and ketone levels in the app. Then, both the patient and I could track their levels and make adjustments accordingly.”

The authors note participants in the study chose to take part in the Virta program or continue with the usual care, and thus were not randomly assigned to either group. In addition, all participants enrolled at the single Indiana site and were largely Caucasian.

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