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: Annals of Internal Medicine: Vol 0, No 0

Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark, and Clinical Research Institute, University of Southern Denmark (CDH, MBH, NT, MK, SJ, KHT, MST)

Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (EMG, HB, KH)

Department of Gastroenterology, Odense University Hospital, Odense, Denmark (JKH, BSM, JMJ, SO, DNR, PA, MI)

Department of Gastroenterology and Hepatology, Odense University Hospital, University of Southern Denmark Clinical Research Institute, Odense SV, Denmark (KPL)

University of Southern Denmark, Odense, Denmark (JCB), Department of Sport Sciences and Clinical Biomechanics

Department of Endocrinology, Odense University Hospital, Odense, Denmark (PH)

University of Southern Denmark Clinical Research Institute, Department of Pathology, Odense University Hospital, Odense, Denmark (SD)

Novo Nordisk Foundation, Center for Basal Metabolic Research, University of Copenhagen, Copenhagen, Denmark (TH)

Department of Gastroenterology and Hepatology, Odense University Hospital, Odense C, Denmark, and Institute for Clinical Research, University of Southern Denmark (AK)

understand: The authors thank all participants in this study. Additionally, the authors thank Louise Just, Vibeke Nielsen, Ida Spedtsberg, and the entire staff of the Odense Liver Research Center. Trine Møller, Minna Ingham, Charlotte Damby Jensen, Line Dan Jensen, Kirsten Dalhøj and all staff in the Department of Gastroenterology and Hepatology. Her Anette Tyrsted and Lea Grip in the Department of Clinical Biochemistry and Pharmacology at Odense University Hospital. and the Open Patient Data Discovery Network Division.

Financial support: Novo Nordisk Foundation (NNF16OC0021038), Southern Denmark Region, University of Southern Denmark, Odense University Hospital, Danish Diabetes Academy, AP Moller Foundation, Overlæge Johan Boserup and Lise Boderups Legat.

Disclosure: Disclosures can be viewed at: www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1787.

Data sharing statement: The following data will be made available upon publication: Anonymized Participant Data. (Interested researchers should contact Dr. Hansen. Camilla.Dalby.[email protected]dk ID: See OP-295 to request and retrieve relevant data. Liver histology data and data from blood analysis are available from the authors upon request to Dr. Hansen. Camilla.Dalby.[email protected]dkStandard operating procedures and patient information are also available upon request. When applying and processing data, certain restrictions of the European Union General Data Protection Regulation apply. This includes that data must not be processed for purposes other than statistical and scientific research and that personal data must be deleted, anonymized and finally destroyed. Access to data shall not be passed to unauthorized third parties or persons. ) The following supporting documents will be made available with the publication: Informed Consent Form (secure SharePoint website). These data will be made available to researchers who are authorized to use the data for any purpose after the proposal has been approved with a signed data access agreement (limitations: none).

Corresponding author: Aleksander Krag, MD, PhD, Odense Liver Research Centre, Department of Gastroenterology and Hepatology, Odense University Hospital, Kloevervaenget 10, Entrance 112, 5000 Odense C, Denmark; email, Alexander.[email protected]dk.

Author contribution: Concept and design: H. Beck-Nielsen, EM Gram-Kampmann, CD Hansen, T. Hansen, JM Jensen, A. Krag.

Data analysis and interpretation: H. Beck-Nielsen, JC Brønd, CD Hansen, T. Hansen, K. Højlund, M. Israelsen, A. Krag, MS Thiele.

Article drafted by: H. Beck-Nielsen, JC Brønd, CD Hansen, K. Højlund, M. Israelsen, JM Jensen, S. Johansen, A. Krag, KH Thorhauge.

Significant revision of article on important intellectual content: H. Beck-Nielsen, S. Detlefsen, CD Hansen, JK Hansen, T. Hansen, P. Hermann, K. Højlund, M. Israelsen, JM Jensen, S. Johansen , M. Kjaergaard, A. Krag, BS Madsen, M.S. Thiele, N. Torp.

Article finalized by: P. Andersen, H. Beck-Nielsen, JC Brønd, S. Detlefsen, E. Gram-Kampmann, CD Hansen, JK Hansen, T. Hansen, P. Hermann, K. Højlund, MB Hugger, M. Israelsen, JM Jensen, S. Johansen, M. Kiergaard, A. Krag, KP Lindvig, BS Madsen, S. Olsen, DN Rasmussen, M. Thiele, KH Thorhousi, N. Torpe.

Research material or patient donations: H. Beck-Nielsen, S. Detlefsen, E. Gram-Kampmann, MB Hugger, A. Krag, S. Olesen.

Funding: H. Beck-Nielsen, E. Gram-Kampmann, CD Hansen, T. Hansen, A. Krag.

Management, Technical or Logistics: P. Andersen, H. Beck-Nielsen, CD Hansen, JK Hansen, P. Hermann, K. Højlund, MB Hugger, JM Jensen, A. Krag, KP Lindvig, S. Olesen.

Data collection and collection: S. Detlefsen, E. Gram-Kampmann, CD Hansen, JK Hansen, MB Hugger, M. Israelsen, JM Jensen, M. Kjaergaard, KP Lindvig, BS Madsen, S. Olesen, N. Torp.

This article was published in Annals.org December 13, 2022.