LAS VEGAS — Patients with type 2 diabetes who received a continuous care treatment including nutritional ketosis improved biomarkers of CVD risk after 1 year compared with the usual care, according to data presented at the National Lipid Association Scientific Sessions.
Although LDL-C increased, it occurred while LDL particle size increased and was limited to a large LDL subfraction, according to the presentation.
Amy McKenzie, PhD, research scientist at Virta Health in San Francisco, and colleagues analyzed data from patients with type 2 diabetes who were treated with a continuous care intervention with nutritional ketosis (n = 262; mean age, 54 years) or the usual care (n = 87; mean age, 52 years).
“Nutritional ketosis is a metabolic state of enhanced fat oxidation where you can more easily access either stored or dietary sources of fat,” McKenzie said during the presentation. “You can do this by significantly reducing your carbohydrate intake and also keeping your protein in moderation.”
Patients in the continuous care intervention group were treated with a dedicated health coach and medical provider. Those in the usual care group were tracked for type 2 diabetes progression.
Researchers examined BP, circulating biomarkers of cholesterol metabolism and inflammation, carotid intima-media thickness, medication and multifactorial risk scores.
At 1 year, patients who received continuous care intervention had decreases in small LDL-P (–20.8%; P = 1.2 x 10-12), apolipoprotein B/apolipoprotein A-I ratio (–9.5%; P = 1.9 x 10-7), triglyceride/HDL-C ratio (–29.1%; P < 10-16) and large VLDL-P (–38.9%; P = 4.2 x 10-15). Increases were also seen in LDL-P size (+1.1%; P = 6 x 10-10) and ApoA-I (+9.8%; P < 10-16). Total LDL particle number (–4.9%; P = .02) and ApoB (–1.6%; P = .37) were statistically unchanged. The usual care group did not have significant changes in biomarkers.
The continuous care intervention group also had reductions in high-sensitivity C-reactive protein, BP and white blood cell count at 1 year (P < 1 x 10-7).
“[BP reduction] actually necessitated a significant deprescription of blood pressure medications, mostly diuretics,” McKenzie said.
Carotid intima-media thickness was unchanged during the study. Ten-year atherosclerotic CVD risk score decreased by 11.9% in patients in the intervention group (P = 4.9 x 10-5).
Compared with the usual care group, the continuous care intervention group had significant improvements in ApoA-I, LDL-P, HDL-C, triglyceride/HDL-C ratio, atherosclerotic CVD score and high-sensitivity CRP, and a greater increase in LDL-C after adjusting for differences in baseline characteristics and multiple comparisons.
The change in LDL particle number from baseline to 70 days was inversely correlated with the change from 70 days to 1 year in the continuous care intervention group (P = 1.6 x 10-9).
“Being a research scientist, this suggests a neutral if not perhaps for some people a positive impact on cardiovascular risk, but at the end of the day, we really have to handle risk management on an individual patient level,” McKenzie said. – by Darlene Dobkowski
McKenzie A, et al. Cardiovascular disease risk factor response to a type 2 diabetes care model including nutritional ketosis at one year. Presented at: National Lipid Association Scientific Sessions; April 26-29, 2018; Las Vegas.
Disclosures: The study was sponsored by Virta Health in collaboration with Indiana University Health Arnett Hospital. McKenzie reports she received a salary and stock options from Virta Health.