Glycemic Control

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

Shaminie J. Athinarayanan, Rebecca N. Adams, Sarah J. Hallberg, Amy L. McKenzie, Nasir H. Bhanpuri, Wayne W. Campbell, Jeff S. Volek, Stephen D. Phinney, James P. McCarter

An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively.  Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. The aim was to assess the effects of a continuous care intervention (CCI) on retention, glycemic control, weight, body composition, cardiovascular, liver, kidney, thyroid, inflammatory markers, diabetes medication usage and disease outcomes at 2 years in adults with type 2 diabetes (T2D).

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Effect of a Low- Carbohydrate Diet on Appetite, Blood Glucose Levels, and Insulin Resistance in Obese Patients with Type 2 Diabetes

Guenther Boden, MD; Karin Sargrad, MS, RD, CDE; Carol Homko, PhD, RN, CDE; Maria Mozzoli, BS; T. Peter Stein, PhD

Single arm – meabolic ward with 10 participants:  In a small group of obese patients with type 2 diabetes, a low-carbohydrate diet followed for 2 weeks resulted in spontaneous reduction in energy intake to a level appropriate to their height; weight loss that was completely accounted for by reduced caloric intake; much improved 24-hour blood glucose profiles, insulin sensitivity, and hemoglobin A1c; and decreased plasma triglyceride and cholesterol levels.

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Short-Term Effects of Severe Dietary Carbohydrate-Restriction Advice in Type 2 Diabetes – a Randomized Controlled Trial

M. E. Daly; R. Paisey; B. A. Millward; C. Eccles; K. Williams; S. Hammersley; K. M. MacLeod; T. J. Gale

RCT with 102 participants:  Weight loss and high-density lipoprotein (HDL) ratio improved was greater in the low-carbohydrate (LC) group over low fat group. Carbohydrate restriction was an effective method of achieving short-term weight loss compared with standard advice.

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The Effect of a Lowcarbohydrate, Ketogenic Diet Versus a Lowglycemic Index Diet on Glycemic Control in Type 2 Diabetes Mellitus

Eric C Westman; William S Yancy Jr; John C Mavropoulos; Megan Marquart; Jennifer R McDuffie

RCT with 84 participants:  Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes. The diet lower in carbohydrate led to greater improvements in glycemic control, and more frequent medication reduction/elimination than the low glycemic index diet. Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes.

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Weight Loss with a Low- Carbohydrate, Mediterranean, or Low- Fat Diet

Iris Shai, RD, PhD; Dan Schwarzfuchs, MD; Yaakov Henkin, MD; Danit R. Shahar, RD, PhD; Shula Witkow, RD, MPH; Ilana Greenberg, RD, MPH; Rachel Golan, RD, MPH; Drora Fraser, PhD; Arkady Bolotin, PhD; Hilel Vardi, MSc; Osnat Tangi-Rozental, BA; Rachel Zuk-Ramot, RN; Benjamin Sarusi, MSc; Dov Brickner, MD; Ziva Schwartz, MD; Einat Sheiner, MD; Rachel Marko, MSc; Esther Katorza, MSc; Joachim Thiery, MD; Georg Martin Fiedler, MD; Matthias Blüher, MD; Michael Stumvoll, MD; Meir J. Stampfer, MD; Dr.PH

RCT – 3 arm with 322 participants:  Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions.

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Comparative Study of the Effects of a 1-Year Dietary Intervention of a Low-Carbohydrate Diet Versus a Low-Fat Diet on Weight and Glycemic Control in Type 2 Diabetes

Nichola J. Davis, MD, MS; Nora Tomuta, MD; Clyde Schechter, MD; Carmen R. Isasi, MD, PHD; C.J. Segal-Isaacson, EDD, RD; Daniel Stein, MD; Joel Zonszein, MD; Judith Wylie-Rosett, EDD, RD

RCT with 105 participants:  Among patients with type 2 diabetes, after 1 year a lowcarbohydrate diet had effects on weight and A1C similar to those seen with a low-fat diet. There was no significant effect on blood pressure, but the low-carbohydrate diet produced a greater increase in HDL cholesterol. Weight loss occurred faster in the low-carbohydrate group than in the low-fat group in the first 3 months.

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A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.

William S. Yancy Jr, MD, MHS; Eric C. Westman, MD, MHS; Jennifer R. McDuffie, PhD, RD, MPH; Steven C. Grambow, PhD; Amy S. Jeffreys, MStat; Jamiyla Bolton, MS; Allison Chalecki, RD; Eugene Z. Oddone, MD, MHS

RCT with 146 participants:  Obese and overweight outpatients were assigned to either a low-carbohydrate ketogenic diet (LCKD) or Orlistat therapy combined with a low fat diet (O + LFD). In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure.

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Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes

Talib A. Hussain, M.B., Ch.B., R.C.G.P.; Thazhumpal C. Mathew, M.Sc., Ph.D., F.R.C.Path.; Ali A. Dashti, M.Sc., Ph.D.; Sami Asfar, M.B., Ch.B., M.D., F.R.C.S., F.A.C.S.; Naji Al-Zaid, B.Sc., Ph.D.; Hussein M. Dashti, M.D., Ph.D., F.I.C.S., F.A.C.S.

Non-randomized 2 arm prospective with 363 participants:  This study shows the beneficial effects of a ketogenic diet over the conventional LCD in obese diabetic subjects.  The ketogenic diet appears to improve glycemic control.  Therefore, diabetic patients on a ketogenic diet should be under strict medical supervision because the LCKD can significantly lower blood glucose levels.

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A Very Low Carbohydrate, Low Saturated Fat Diet for Type 2 Diabetes Management: A Randomized Trial

Jeannie Tay, Natalie D. Luscombe-Marsh, Campbell H. Thompson, Manny Noakes, Jon D. Buckley, Gary A. Wittert, William S. Yancy Jr., Grant D. Brinkworth

RCT with 93 participants.  Both diets achieved substantial improvements for several clinical glycemic control and CVD risk markers.  These improvements and reductions in GV and anti-glycemic medication requirements were greatest with the LC compared with HC.  This suggests an LC diet with low saturated fat may be an effective dietary approach for T2DM management if effects are sustained beyond 24 weeks.   (It should be noted that a Low-Carb/ High[er]-Saturated-Fat diet was not included in the trial).

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A Randomized Pilot Trial of a Moderate Carbohydrate Diet Compared to a Very Low Carbohydrate Diet in Overweight or Obese Individuals with Type 2 Diabetes Mellitus or Prediabetes

Laura R. Saslow, Sarah Kim, Jennifer J. Daubenmier, Judith T. Moskowitz, Stephen D. Phinney, Veronica Goldman, Elizabeth J. Murphy, Rachel M. Cox, Patricia Moran, Fredrick M. Hecht

RCT with 34 participants.  Results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications.

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Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very lowcarbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes

Laura R. Saslow, Jennifer J. Daubenmier, Judith T. Moskowitz, Sarah Kim, Elizabeth J. Murphy, Stephen D. Phinney, Robert Ploutz-Snyder, Veronica Goldman, Rachel M. Cox, Ashley E. Mason, Patricia Moran & Frederick M. Hecht

RCT with 34 particpants.  The results suggest that adults with prediabetes or noninsulin-dependent type 2 diabetes may be able to improve glycemic control with less medication by following an ad libitum very low-carbohydrate ketogenic diet compared to a moderate-carbohydrate, calorie-restricted low-fat diet. Additional research should examine both clinical outcomes and adherence beyond 12 months.

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A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes

Amy L McKenzie, PhD ; Sarah J Hallberg, DO, MS ; Brent C Creighton, PhD ; Brittanie M Volk, RD, PhD ; Theresa M Link, RD, CDE ; Marcy K Abner, RD ; Roberta M Glon, RN, BSN ; James P McCarter, MD, PhD ; Jeff S Volek, RD, PhD ; Stephen D Phinney, MD, PhD

This study, non-randomized parallel arm prospective with 262 participants, demonstrates an individualized program delivered and supported remotely that incorporates nutritional ketosis can be highly effective in improving glycemic control and weight loss in adults with T2D while significantly decreasing medication use.

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Management of Type 1 Diabetes With a Very Low–Carbohydrate Diet

Belinda S. Lennerz, Anna Barton, Richard K. Bernstein, R. David Dikeman, Carrie Diulus, Sarah Hallberg, Erinn T. Rhodes, Cara B. Ebbeling, Eric C. Westman, William S. Yancy Jr, David S. Ludwig

To evaluate glycemic control among children and adults with type 1 diabetes mellitus (T1DM) who consume a very low–carbohydrate diet (VLCD).

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