Unlike in DiRECT, patients were allowed to take insulin at study onset (30% in the low-carbohydrate group and 46% in the usual care group). After 1 year, patients in the usual care group had no significant changes in study biomarkers.
Conversely, 60% of those in the low-carbohydrate group achieved an A1c level < 6.5 while taking no diabetes medications or metformin only. There was also a 12% weight loss, 24% reduction in triglyceride level, 18% increase in high-density lipoprotein cholesterol level, and 39% reduction in C-reactive protein level.
According to Sarah Hallberg, DO, the study's principal investigator and medical director of Virta Health and Indiana University Arnett's Medically Supervised Weight Loss Program, the 94% rate of reduction or outright cessation of insulin in this group is particularly noteworthy.