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Cited by 111Diet and metabolism studiesDietary Effects on HealthDiabetes Management and Research

The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.

Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Hansen, Camilla Dalby, Gram-Kampmann, Eva-Marie, Hansen, Johanne Kragh, Hugger, Mie Balle, Madsen, Bjørn Stæhr, Jensen, Jane Møller, Olesen, Sara, Torp, Nikolaj, Rasmussen, Ditlev Nytoft, Kjærgaard, Maria, Johansen, Stine, Lindvig, Katrine Prier, Andersen, Peter, Thorhauge, Katrine Holtz, Brønd, Jan Christian, Hermann, Pernille, Beck-Nielsen, Henning, Detlefsen, Sönke, Hansen, Torben, Højlund, Kurt, Thiele, Maja Sofie, Israelsen, Mads, Krag, Aleksander·2023·Annals of Internal Medicine
DOI 10.7326/m22-1787
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Abstract

BACKGROUND: It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated. OBJECTIVE: To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet. DESIGN: 6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078). SETTING: Odense University Hospital in Denmark from November 2016 until June 2020. PARTICIPANTS: 165 participants with T2DM. INTERVENTION: Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins. MEASUREMENTS: Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD. RESULTS: (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up. LIMITATION: Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons. CONCLUSION: Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention. PRIMARY FUNDING SOURCE: Novo Nordisk Foundation.

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Metadata

Authors
Hansen, C. D., Gram-Kampmann, E.-M., Hansen, J. K., Hugger, M. B., Madsen, B. S., Jensen, J. M., Olesen, S., Torp, N., Rasmussen, D. N., Kjærgaard, M., Johansen, S., Lindvig, K. P., Andersen, P., Thorhauge, K. H., Brønd, J. C., Hermann, P., Beck-Nielsen, H., Detlefsen, S., Hansen, T., Højlund, K., Thiele, M. S., Israelsen, M., & Krag, A.
Affiliations
  • University of Southern Denmark (DK)
  • Odense University Hospital (DK)
  • Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark (P.H.)
  • Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (E.M.G., H.B., K.H.)
  • University of Copenhagen (DK)
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2023-01
Volume
176
Issue
1
Pages
10-21
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/m22-1787
OpenAlex
W4311286960
Cited by
110
References
38
Citations by year
2026: 20 · 2025: 37 · 2024: 37 · 2023: 16
FWCI
13.93
Type
journal article
Language
en
Open access
closed
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Topics
  • Health Sciences › Medicine › Physiology (medical) › Diet and metabolism studies
  • Health Sciences › Medicine › Physiology (medical) › Dietary Effects on Health
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
low-carbohydrate high-fat diet, type 2 diabetes, non-alcoholic fatty liver disease, high-carbohydrate low-fat diet, glycemic control, HbA1c, serum lipids, triglycerides, HDL cholesterol, LDL cholesterol, weight loss, liver biopsy, dietary intervention, metabolic biomarkers, liver fibrosis, steatosis
MeSH terms
Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Weight Loss, Diet, Fat-Restricted, Diet, Carbohydrate-Restricted, Diet, High-Fat, Non-alcoholic Fatty Liver Disease

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