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

Affiliations:

Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense, Denmark (C.D.H., M.B.H., N.T., M.K., S.J., K.H.T., M.S.T.)

Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (E.M.G., H.B., K.H.)

Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark (J.K.H., B.S.M., J.M.J., S.O., D.N.R., P.A., M.I.)

Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense SV, Denmark (K.P.L.)

Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark (J.C.B.)

Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark (P.H.)

Institute of Clinical Research, University of Southern Denmark, and Department of Pathology, Odense University Hospital, Odense, Denmark (S.D.)

Novo Nordisk Foundation, Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark (T.H.)

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

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

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

Disclosures: 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 with publication: deidentified participant data. (Interested researchers may contact Dr. Hansen at camilla.dalby.[email protected]dk to request and obtain relevant data with reference to ID: OP-295. Liver histology data and data from blood analysis will be available from the authors on request to Dr. Hansen at camilla.dalby.[email protected]dk. The standard operating procedures and patient information will also be available on request. When applying and processing the data, certain restrictions from the European Union General Data Protection Regulation apply, including that the data must not be processed for purposes other than statistical and scientific studies and personal data must be deleted, anonymized, and destroyed at the end of investigation and must not be passed on to a third party or persons who are not authorized to access the data.) The following supporting documents will be made available with publication: informed consent form (secure SharePoint website). These data will be made available to researchers whose proposed use of the data has been approved, for any purpose, after approval of a proposal with a signed data access agreement (restrictions: 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; e-mail, aleksander.[email protected]dk.

Author Contributions: Conception and design: H. Beck-Nielsen, E.M. Gram-Kampmann, C.D. Hansen, T. Hansen, J.M. Jensen, A. Krag.

Analysis and interpretation of the data: H. Beck-Nielsen, J.C. Brønd, C.D. Hansen, T. Hansen, K. Højlund, M. Israelsen, A. Krag, M.S. Thiele.

Drafting of the article: H. Beck-Nielsen, J.C. Brønd, C.D. Hansen, K. Højlund, M. Israelsen, J.M. Jensen, S. Johansen, A. Krag, K.H. Thorhauge.

Critical revision of the article for important intellectual content: H. Beck-Nielsen, S. Detlefsen, C.D. Hansen, J.K. Hansen, T. Hansen, P. Hermann, K. Højlund, M. Israelsen, J.M. Jensen, S. Johansen, M. Kjaergaard, A. Krag, B.S. Madsen, M.S. Thiele, N. Torp.

Final approval of the article: P. Andersen, H. Beck-Nielsen, J.C. Brønd, S. Detlefsen, E. Gram-Kampmann, C.D. Hansen, J.K. Hansen, T. Hansen, P. Hermann, K. Højlund, M.B. Hugger, M. Israelsen, J.M. Jensen, S. Johansen, M. Kjaergaard, A. Krag, K.P. Lindvig, B.S. Madsen, S. Olesen, D.N. Rasmussen, M. Thiele, K.H. Thorhauge, N. Torp.

Provision of study materials or patients: H. Beck-Nielsen, S. Detlefsen, E. Gram-Kampmann, M.B. Hugger, A. Krag, S. Olesen.

Obtaining of funding: H. Beck-Nielsen, E. Gram-Kampmann, C.D. Hansen, T. Hansen, A. Krag.

Administrative, technical, or logistic support: P. Andersen, H. Beck-Nielsen, C.D. Hansen, J.K. Hansen, P. Hermann, K. Højlund, M.B. Hugger, J.M. Jensen, A. Krag, K.P. Lindvig, S. Olesen.

Collection and assembly of data: S. Detlefsen, E. Gram-Kampmann, C.D. Hansen, J.K. Hansen, M.B. Hugger, M. Israelsen, J.M. Jensen, M. Kjaergaard, K.P. Lindvig, B.S. Madsen, S. Olesen, N. Torp.

This article was published at Annals.org on 13 December 2022.