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
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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.
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Studies utilizing carbohydrate restriction observed improved glycemic control and cardiometabolic markers, but were often short-term trials of small groups, excluded subjects prescribed insulin, or infrequently monitored or achieved ketosis.
“Studies utilizing carbohydrate restriction observed improved glycemic control and cardiometabolic markers, but were often short-term trials of small groups, excluded subjects prescribed insulin, or infrequently monitored or achieved ketosis [16–20].”
From 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 (2018) · cites this paper as [19]
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- Authors
- Saslow, L. R., Kim, S., Daubenmier, J. J., Moskowitz, J. T., Phinney, S. D., Goldman, V., Murphy, E. J., Cox, R. M., Moran, P., & Hecht, F. M.
- Affiliations
- University of California, San Francisco (US)
- University of California, Davis (US)
- Corresponding author
- Saslow, Laura R.
- ORCID
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2014-04-09
- Volume
- 9
- Issue
- 4
- Pages
- e91027
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3981696
- OpenAlex
- W2035829927
- Cited by
- 221
- References
- 37
- Citations by year
- 2026: 6 · 2025: 17 · 2024: 15 · 2023: 28 · 2022: 30 · 2021: 24 · 2020: 25 · 2019: 15 · 2018: 29 · 2017: 16 · 2016: 10 · 2015: 5 · 2014: 1
- FWCI
- 7.11
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Figshare (submittedVersion, cc-by)
- Funders
- National Institutes of Health
- National Institute of Mental Health (K24MH093225, MH093225)
- National Center for Complementary and Alternative Medicine
- National Center for Complementary and Integrative Health (K24AT007827, T32AT003997)
- Topics
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- very low carbohydrate diet, type 2 diabetes, prediabetes, obesity, overweight, glycemic control, HbA1c, nutritional ketosis, caloric restriction, carbohydrate counting, weight loss, sulfonylureas
- MeSH terms
- Blood Glucose, Body Weight, Demography, Diabetes Mellitus, Type 2, Fasting, Female, Glycated Hemoglobin, Humans, Male, Middle Aged, Obesity, Prediabetic State, Triglycerides, Diet, Carbohydrate-Restricted
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