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

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

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

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

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

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

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

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

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

Thanks: The authors thank all participants in this study. The authors also thank Louise Just, Vibeke Nielsen, Ida Spedtsberg and all staff at 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; Anette Tyrsted and Lea Grip from the Department of Clinical Biochemistry and Pharmacology at Odense University Hospital; and the Open Patient Data Discovery Network Department.

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

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

Data Sharing Statement: The following data will be made available after publication: anonymous participant data. (Interested researchers can contact Dr. Hansen at: camilladalby[email protected]min Request and obtain relevant data by reference to ID: OP-295. Liver histology data and data from blood analysis are available upon request from co-author Dr. It will be provided to Hansen at: camilladalby[email protected]min. Standard operating procedures and patient information are also available upon request. When applying and processing data, certain restrictions from the European Union General Data Protection Regulation apply, including not processing the data for purposes other than statistical and scientific studies, and deletion, anonymization and eventual destruction of personal data. should not be passed on to third parties or persons who are not authorized to investigate and access data.) The following supporting documents will be provided with the publication: informed consent form (secure SharePoint website). These data will be made available to researchers whose data is proposed to be used for any purpose, after approval of a proposal with a signed data access agreement (restrictions: none).

Responsible Author: Aleksander Krag, MD, PhD, Odense Liver Research Center, Department of Gastroenterology and Hepatology, Odense University Hospital, Kloevervaenget 10, Entry 112, 5000 Odense C, Denmark; email, Iskender[email protected]min.

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

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

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

Critical revision of the article for 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, MS Thiele, N. Torp.

Final approval of article: 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. Kjaergaard, A. Krag, KP Lindvig, BS Madsen, S. Olesen, DN Rasmussen, M. Thiele, KH Thorhauge, N. Torp.

Provision of study materials or patients: 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.

Administrative, technical or logistical support: 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 consolidation: 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 on Annals.org on December 13, 2022.