Abstract
Novel lifestyle, pharmaceutical, and/or surgical therapies for type 2 diabetes (T2D) are under study to assess lasting impact on metabolic risk. Among them, carbohydrate restriction including nutritional ketosis (CR) has emerged as a safe and effective nutrition therapy for reducing hyperglycemia in patients with T2D1, yet longer term effects are unknown. At the conclusion of a 2-year study assessing a continuous remote care intervention utilizing CR (CCI) among patients who selected this therapy, intervention participants were offered the opportunity to consent to participate in a 3-year extension assessing outcomes at 3.5- and 5-y following initial enrollment. 143 of 169 extension-consented participants provided data at 3.5-y follow up. Among 3.5-y completers, linear mixed effects models were used to assess change over time in diabetes-related outcomes and McNemar’s tests were used to assess for a difference in the proportion of participants meeting certain criteria at baseline compared to follow-up. At enrollment, 3.5-y completers were (mean±SE) 55±1 y of age, 40.8±0.7 kg/m2, and 8±1 y since diagnosis. Following treatment with the CCI for 3.5 y, significant improvements compared to baseline were observed in HbA1c (-0.6±0.1 from 7.4±0.1%; P = 1.9x10-5), weight (-10.9±1.1 from 117.4 kg; P = 6.9x10-17), nonHDL-C (-10±4 from 139±3 mg/dL; P = 0.005), triglycerides (-41±11 from 189±10 mg/dl; P = 2.1x10-4), and HDL-C (+9±1 from 43±1 mg/dl; P = 3.0x10-11); total cholesterol and LDL-C were statistically unchanged. The percentage of participants prescribed diabetes medication decreased from 84.6 to 67.1% (P = 5.0x10-6), while 50.2% of diabetes medications and 71.4% of diabetes medications other than metformin were discontinued. The percentage of participants treated with no pharmaceuticals or monotherapy increased from 52.5 to 81.9% (P = 1.3x10-8). 45.5% (65/143) of participants achieved HbA1c <6.5% with either no medication (34/65, 52%) or only metformin (31/65, 48%) at 3.5 y; 37.8% of participants maintained this status from 1 through 3.5 y of treatment. 22% of participants achieved diabetes remission at 3.5 y, and 17.5% of participants maintained remission status from 2 through 3.5 y of treatment. This demonstrates that clinically meaningful improvements across multiple markers of metabolic risk can be sustained in patients with T2D who selected treatment with this CCI for 3.5 y. Improvements in metabolic risk markers reduced the need for diabetes medication, allowing some patients to achieve and sustain diabetes remission. This ongoing trial will assess 5-y effects.
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Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success
