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 - PubMed (original) (raw)
Randomized Controlled Trial
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 et al. PLoS One. 2014.
Abstract
We compared the effects of two diets on glycated hemoglobin (HbA1c) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes (HbA1c>6%). We randomized participants to either a medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet (MCCR) consistent with guidelines from the American Diabetes Association (n = 18) or a very low carbohydrate, high fat, non calorie-restricted diet whose goal was to induce nutritional ketosis (LCK, n = 16). We excluded participants receiving insulin; 74% were taking oral diabetes medications. Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance. At 3 months, mean HbA1c level was unchanged from baseline in the MCCR diet group, while it decreased 0.6% in the LCK group; there was a significant between group difference in HbA1c change favoring the LCK group (-0.6%, 95% CI, -1.1% to -0.03%, p = 0.04). Forty-four percent of the LCK group discontinued one or more diabetes medications, compared to 11% of the MCCR group (p = 0.03); 31% discontinued sulfonylureas in the LCK group, compared to 5% in the MCCR group (p = 0.05). The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group (p = 0.09). Our 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. This clinical trial was registered with ClinicalTrials.gov, number NCT01713764.
Conflict of interest statement
Competing Interests: The authors have declared that no competing interests exist.
Figures
Figure 1. Study participant flowchart.
LCK = Low carbohydrate diet group. MCCR = Medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet.
Figure 2. Change in HbA1c by diet group.
Both panels show individual lines for the course of HbA1c from baseline to 3 months after intervention initiation for each trial participant. The left panel displays this data for the low carbohydrate diet group (mean change −0.6%), while the right presents the data for the moderate carbohydrate diet group (mean change 0%). See text for further discussion.
Figure 3. Relationship between change in hemoglobin A1c and change in weight.
The figure plots the change in HbA1c vs. the change in weight from baseline to 3 months for each individual (Spearman rank correlations: LCK = 0.45, p = 0.096; MCCR = 0.47, p = 0.055). The LCK group is shown as open circles; the MCCR group is shown as diamonds.
Figure 4. Change in weight by diet group.
Both panels show individual lines for the course of weight from baseline to 3 months after intervention initiation for each trial participant. The left panel displays this data for the low carbohydrate diet group (mean change −5.5 kg), while the right presents the data for the moderate carbohydrate diet group (mean change −2.6 kg).
Figure 5. Change in fasting glucose by diet group.
Both panels show individual lines for the course of fasting glucose from baseline to 3 months after intervention initiation for each trial participant. The left panel displays this data for the low carbohydrate diet group (mean change −11.1 mg/dL), while the right presents the data for the moderate carbohydrate diet group (mean change −1.2 mg/dL).
Figure 6. Change in triglycerides by diet group.
Both panels show individual lines for the course of triglycerides from baseline to 3 months after intervention initiation for each trial participant. The left panel displays this data for the low carbohydrate diet group (mean change −22.3 mg/dL), while the right presents the data for the moderate carbohydrate diet group (mean change −3.9 mg/dL).
Similar articles
- 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.
Saslow LR, Daubenmier JJ, Moskowitz JT, Kim S, Murphy EJ, Phinney SD, Ploutz-Snyder R, Goldman V, Cox RM, Mason AE, Moran P, Hecht FM. Saslow LR, et al. Nutr Diabetes. 2017 Dec 21;7(12):304. doi: 10.1038/s41387-017-0006-9. Nutr Diabetes. 2017. PMID: 29269731 Free PMC article. Clinical Trial. - Effects of a Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial.
Esposito K, Maiorino MI, Ciotola M, Di Palo C, Scognamiglio P, Gicchino M, Petrizzo M, Saccomanno F, Beneduce F, Ceriello A, Giugliano D. Esposito K, et al. Ann Intern Med. 2009 Sep 1;151(5):306-14. doi: 10.7326/0003-4819-151-5-200909010-00004. Ann Intern Med. 2009. PMID: 19721018 Clinical Trial. - Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes.
Hussain TA, Mathew TC, Dashti AA, Asfar S, Al-Zaid N, Dashti HM. Hussain TA, et al. Nutrition. 2012 Oct;28(10):1016-21. doi: 10.1016/j.nut.2012.01.016. Epub 2012 Jun 5. Nutrition. 2012. PMID: 22673594 Clinical Trial. - Effects of low carbohydrate diets on weight and glycemic control among type 2 diabetes individuals: a systemic review of RCT greater than 12 weeks.
Castañeda-González LM, Bacardí Gascón M, Jiménez Cruz A. Castañeda-González LM, et al. Nutr Hosp. 2011 Nov-Dec;26(6):1270-6. doi: 10.1590/S0212-16112011000600013. Nutr Hosp. 2011. PMID: 22411372 Review. - Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.
Franz MJ, Boucher JL, Rutten-Ramos S, VanWormer JJ. Franz MJ, et al. J Acad Nutr Diet. 2015 Sep;115(9):1447-63. doi: 10.1016/j.jand.2015.02.031. Epub 2015 Apr 29. J Acad Nutr Diet. 2015. PMID: 25935570 Review.
Cited by
- Modern Challenges in Type 2 Diabetes: Balancing New Medications with Multifactorial Care.
Caturano A, Galiero R, Rocco M, Tagliaferri G, Piacevole A, Nilo D, Di Lorenzo G, Sardu C, Vetrano E, Monda M, Marfella R, Rinaldi L, Sasso FC. Caturano A, et al. Biomedicines. 2024 Sep 7;12(9):2039. doi: 10.3390/biomedicines12092039. Biomedicines. 2024. PMID: 39335551 Free PMC article. Review. - Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes.
Berube LT, Popp CJ, Curran M, Hu L, Pompeii ML, Barua S, Bernstein E, Salcedo V, Li H, St-Jules DE, Segal E, Bergman M, Williams NJ, Sevick MA. Berube LT, et al. Trials. 2024 Jul 25;25(1):506. doi: 10.1186/s13063-024-08337-w. Trials. 2024. PMID: 39049121 Free PMC article. - Impact of very low carbohydrate ketogenic diets on cardiovascular risk factors among patients with type 2 diabetes; GRADE-assessed systematic review and meta-analysis of clinical trials.
Ghasemi P, Jafari M, Maskouni SJ, Hosseini SA, Amiri R, Hejazi J, Chambari M, Tavasolian R, Rahimlou M. Ghasemi P, et al. Nutr Metab (Lond). 2024 Jul 19;21(1):50. doi: 10.1186/s12986-024-00824-w. Nutr Metab (Lond). 2024. PMID: 39030553 Free PMC article. - Methodological Challenges and Confounders in Research on the Effects of Ketogenic Diets: A Literature Review of Meta-Analyses.
Szendi K, Murányi E, Hunter N, Németh B. Szendi K, et al. Foods. 2024 Jan 12;13(2):248. doi: 10.3390/foods13020248. Foods. 2024. PMID: 38254549 Free PMC article. Review. - Comparative Evaluation of a Low-Carbohydrate Diet and a Mediterranean Diet in Overweight/Obese Patients with Type 2 Diabetes Mellitus: A 16-Week Intervention Study.
Currenti W, Losavio F, Quiete S, Alanazi AM, Messina G, Polito R, Ciolli F, Zappalà RS, Galvano F, Cincione RI. Currenti W, et al. Nutrients. 2023 Dec 27;16(1):95. doi: 10.3390/nu16010095. Nutrients. 2023. PMID: 38201924 Free PMC article.
References
- Association AD (2009) All About Carbohydrate Counting.
Publication types
MeSH terms
Substances
Grants and funding
- K24 AT007827/AT/NCCIH NIH HHS/United States
- K24 MH093225/MH/NIMH NIH HHS/United States
- T32 AT003997/AT/NCCIH NIH HHS/United States
- T32AT003997/AT/NCCIH NIH HHS/United States
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Miscellaneous