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Clinical Controlled Trials

Amy L. McKenziea, Shaminie J. Athinarayananb, Michelle R. Van Tieghem, Brittanie M. Volk, Caroline G.P. Roberts, Rebecca N. Adams, Jeff S. Volek, Stephen D. Phinney, Sarah J. Hallberg; 2024: 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study

Athinarayanan, S.J., Vantieghem, M., McKenzie, A.L., Hallberg, S., Roberts, C.G., Volk, B.M., Adams, R.N., Ratner, R.E., Volek, J. and Phinney, S., 2022. 832-P: Five-Year weight and glycemic outcomes following a very-low-carbohydrate intervention including nutritional ketosis in patients with type 2 diabetes. Diabetes, 71(Supplement_1).

Hallberg, S.J., McKenzie, A.L., Williams, P.T., Bhanpuri, N.H., Peters, A.L., Campbell, W.W., Hazbun, T.L., Volk, B.M., McCarter, J.P., Phinney, S.D. and Volek, J.S., 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. Diabetes Therapy, 9(2), pp.583-612.

Durrer C, McKelvey S, Singer J, et al. A randomized controlled trial of
pharmacist-led therapeutic carbohydrate and energy restriction in type 2
diabetes.
Nat Commun. 2021;12(1):5367. doi:10.1038/s41467-021-25667-4

Han, Y. et al. (2021) ‘A Low-Carbohydrate Diet Realizes Medication Withdrawal:
A Possible Opportunity for Effective Glycemic Control’, Frontiers in
Endocrinology, 12. doi:10.3389/fendo.2021.779636.

Moriconi E, Camajani E, Fabbri A, Lenzi A, Caprio M. Very-Low-Calorie
Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic

Management in Patients with Obesity and Type 2 Diabetes. Nutrients.
2021;13(3):758. doi:10.3390/nu13030758

Karkee A, Singh S, Shrestha PK, Shakya NS, Shrestha S, Niroula S. Effect of
Dietary Intervention Using Low-Carbohydrate Diet to Manage Newly Diagnosed

Type 2 Diabetes Mellitus in TUTH Hospital, Nepal. Nepalese Medical Journal.
2021;4(1):419-423. doi:10.3126/nmj.v4i1.34710

Soto-Mota A, Norwitz NG, Evans R, Clarke K, Barber TM. Exogenous ketosis in
patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control.

Endocrinology, Diabetes & Metabolism. 2021, n/a(n/a):e00264.
doi:https://doi.org/10.1002/edm2.264

Wolver S, Fadel K, Fieger E, et al. Clinical Use of a Real-World Low
Carbohydrate Diet Resulting in Reduction of Insulin Dose, Hemoglobin A1c, and
Weight.
Front Nutr. 2021;8:690855. doi:10.3389/fnut.2021.690855

Ahmed SR, Bellamkonda S, Zilbermint M, Wang J, Kalyani RR. Effects of the low
carbohydrate, high fat diet on glycemic control and body weight in patients with
type 2 diabetes: experience from a community-based cohort. BMJ Open Diabetes
Res Care. 2020;8(1). doi:10.1136/bmjdrc-2019-000980

Chen C-Y, Huang W-S, Chen H-C, et al. Effect of a 90 g/day low-carbohydrate
diet on glycaemic control, small, dense low-density lipoprotein and carotid intima-
media thickness in type 2 diabetic patients: An 18-month randomised controlled
trial. PLOS ONE. 2020;15(10):e0240158. doi:10.1371/journal.pone.0240158

Laza-Cagigas R, Chan S, Sumner D, Rampal T. Effects and feasibility of a
prehabilitation programme incorporating a low-carbohydrate, high-fat dietary
approach in patients with type 2 diabetes: A retrospective study. Diabetes Metab
Syndr. 2020;14(3):257-263. doi:10.1016/j.dsx.2020.03.010

McKenzie A, Athinarayanan S, Adams R, Volek J, Phinney S, Hallberg S. SUN-
LB113 A
Continuous Remote Care Intervention Utilizing Carbohydrate Restriction
Including Nutritional Ketosis Improves Markers of Metabolic Risk and Reduces

Diabetes Medication Use in Patients With Type 2 Diabetes Over 3.5 Years. J
Endocr Soc. 2020;4(Supplement_1). doi:10.1210/jendso/bvaa046.2302 (5 Year
Data https://doi.org/10.2337/db22-832-P )

Thomsen MN, Skytte MJ, Astrup A, et al. The clinical effects of a carbohydrate-
reduced high-protein diet on glycaemic variability in metformin-treated patients
with type 2 diabetes mellitus: A randomised controlled study. Clinical Nutrition
ESPEN. Published online August 1, 2020. doi:10.1016/j.clnesp.2020.07.002

Athinarayanan SJ, Adams RN, Hallberg SJ, et al. Long-Term Effects of a Novel
Continuous Remote Care Intervention Including Nutritional Ketosis for the
Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front
Endocrinol. 2019;10. doi:10.3389/fendo.2019.00348

Govers E, Otten A, Schuiling B, Bouwman W, Visscher T. Effectiveness of the 6 ×
6 Dieet® in Obese DMT2 Patients Effectiveness of a Very Low Carbohydrate
Ketogenic Diet Compared to a Low Carbohydrate and Energy-Restricted Diet in
Overweight/Obese Type 2 Diabetes Patients. September 2019.
doi:10.16966/2380-548X.158

Romano L, Marchetti M, Gualtieri P, et al. Effects of a Personalized VLCKD on
Body Composition and Resting Energy Expenditure in the Reversal of Diabetes
to Prevent Complications. Nutrients. 2019;11(7):1526. doi:10.3390/nu11071526

Taylor PJ, Thompson CH, Luscombe-Marsh ND, Wycherley TP, Wittert G,
Brinkworth GD. Efficacy of Real-Time Continuous Glucose Monitoring to Improve
Effects of a Prescriptive Lifestyle Intervention in Type 2 Diabetes: A Pilot Study.
Diabetes Ther. 2019;10(2):509-522. doi:10.1007/s13300-019-0572-z

Tay J, Thompson CH, Luscombe-Marsh ND, et al. Effects of an energy-restricted
low-carbohydrate, high unsaturated fat/low saturated fat diet versus a high-
carbohydrate, low-fat diet in type 2 diabetes: A 2-year randomized clinical trial.
Diabetes Obes Metab. 2018;20(4):858-871. doi:10.1111/dom.13164

Saslow LR, Daubenmier JJ, Moskowitz JT, et al. Twelve-month outcomes of a
randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in
overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes.
2017;7(12):304. doi:10.1038/s41387-017-0006-9

Goday A, Bellido D, Sajoux I, et al. Short-term safety, tolerability and efficacy of a
very low-calorie-ketogenic diet interventional weight loss program versus
hypocaloric diet in patients with type 2 diabetes mellitus. Nutr Diabetes.
2016;6(9):e230. doi:10.1038/nutd.2016.36

Guldbrand H, Lindström T, Dizdar B, et al. Randomization to a low-carbohydrate
diet advice improves health related quality of life compared with a low-fat diet at
similar weight-loss in Type 2 diabetes mellitus. Diabetes Res Clin Pract.
2014;106(2):221-227. doi:10.1016/j.diabres.2014.08.032

Tay J, Luscombe-Marsh ND, Thompson CH, Noakes M, Buckley JD, Wittert GA, et al. Comparison of low-and high-carbohydrate diets for type 2 diabetes management: a randomized trial. The American journal of clinical nutrition. 2015;102(4):780-90.

Tay J, Luscombe-Marsh ND, Thompson CH, et al. A very low-carbohydrate, low-
saturated fat diet for type 2 diabetes management: a randomized trial. Diabetes
Care. 2014;37(11):2909-2918. doi:10.2337/dc14-0845

Yamada Y, Uchida J, Izumi H, et al. A Non-calorie-restricted Low-carbohydrate
Diet is Effective as an Alternative Therapy for Patients with Type 2 Diabetes.
Internal Medicine. 2014;53(1):13-19. doi:10.2169/internalmedicine.53.0861

Nielsen JV, Joensson EA. Low-carbohydrate diet in type 2 diabetes: stable
improvement of bodyweight and glycemic control during 44 months follow-up.
Nutrition & Metabolism. 2008;5(1):14. doi:10.1186/1743-7075-5-14

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