In June of 2017 results of a 10-week outpatient study using a ketogenic diet intervention were published and demonstrated significant improvements in subject’s body weight, glycated hemoglobin (HbA1C) and medication usage. One year follow-up data has just been published demonstrating that reversal of Type 2 Diabetes symptoms is sustainable over the long term, as participants continue to eat a ketogenic diet.
There were 238 participants enrolled in the continuous care intervention at the beginning of the study and all had a diagnosis of Type 2 Diabetes (T2D) when the study began, with an average HbA1c of 7.6% ±1.5%.
Participants ranged in age from 46 – 62 years of age (mean age = 54 years). Sixty-seven (67%) of participants were women and 33% were men.
Weight ranged from 200 pounds to 314 pounds (117±26 kg), with an average weight of 257 pounds (117 kg). Average Body Mass Index (BMI) was 41 kg·m-2 (class III obesity) ±9 kg·m-2, with 82% categorized as obese.
The majority of participants (87%) were taking at least 1 glycemic control medication at the beginning of the study.
At the end of a year, 218 participants (83%) remained enrolled in the continuous care intervention group.
Each participant received an Individualized Meal Plan for nutritional ketosis, behavioral and social support, biomarker tracking tools, and ongoing care from a health coach with medication management by a physician.
Subjects typically required <30 g·day−1 total dietary carbohydrates. Daily protein intake was targeted to a level of 1.5 g·kg−1 based on ideal body weight and participants were coached to incorporate dietary fats until they were no longer hungry. Other aspects of the diet were individually tailored to ensure safety, effectiveness and satisfaction, including consumption of 3-5 servings of non-starchy vegetables and enough mineral and fluid intake. The blood ketone level of β-hydroxybutyrate was monitored using a portable, handheld device.
Ten Week and One Year Outcomes
At baseline, 87% of participants were taking at least one medication for Diabetes and at 10 weeks, almost 57% had one or more Diabetes medications reduced or eliminated.
After one year, Type 2 Diabetes medication prescriptions other than metformin declined from 57% to just below 30%.
Insulin therapy was reduced or eliminated in 94% of users and sulfonylurea medication was entirely eliminated in the continuous care intervention group.
Glycosylated Hemoglobin (HbA1C)
At baseline, the average HbA1c level was 7.6% ±1.5%, with less than 20% of participants having a HbA1c level of <6.5% (with medication usage).
After 10 weeks, HbA1c level was reduced by 1.0% and the percentage of individuals with an HbA1c level of <6.5% was 56%.
On average after 1 year, participants in the intervention group lowered HbA1c from 7.6% to 6.3% – which is in the sub-Diabetes range.
At 10 weeks, mean body mass reduction was 7.2% from a baseline average of 117 kg (257.4 pounds) ±26 kg / 57 lbs.
At one year, mean body mass reduction of participants was 12% of their initial body weight.
Other Metabolic Markers
At 10 months, participants experienced a 20% reduction in triglycerides and after one year, reduction in triglycerides was at 24%. After one year, LDL increased on average by 10% however HDL increased on average by 18%. Serum creatinine and liver enzymes (ALT, AST, and ALP) also declined.
This intervention study demonstrated that individualized nutrition care plans that encourage nutritional ketosis can significantly resukt in reduced weight, HbA1c and medication use within 10 weeks, and that these outcomes can be sustained, or even improved on over the long term, as participants continue to eat a ketogenic diet.
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To our good health,
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McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD, 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, URL: http://diabetes.jmir.org/2017/1/e5, DOI: 10.2196/diabetes.6981
Hallberg, S.J., McKenzie, A.L., Williams, P.T. et al. Diabetes Ther (2018). Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. https://doi.org/10.1007/s13300-018-0373-9