Effect of a low-carb, high-fat diet without calorie restriction versus a high-carb, low-fat diet on type 2 diabetes and non-alcoholic fatty liver disease: a randomized controlled trial: Annals of Internal Medicine: Vol 0, No 0

Memberships:

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 Sports Science 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)

Acknowledgement: The authors thank all participants in this study. In addition, the authors 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, Odense University Hospital; and the Open Patient Data Mining Network Department.

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

Disclosures: The 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 can contact Dr. Hansen at Camille.Dalby.[email protected]ns to request and obtain relevant data with reference to ID: OP-295. Liver histology data and blood analysis data will be available from the authors upon request from Dr. Hansen at Camille.Dalby.[email protected]ns. Standard operating procedures and patient information will also be available upon request. When applying and processing the data, certain restrictions of the General Data Protection Regulation of the European Union apply, in particular that the data must not be processed for purposes other than statistical and scientific studies and that the personal data must be deleted, anonymized and destroyed at the end of the investigation and must not be transmitted to a third party or to persons not authorized to access the data.) The following supporting documents will be made available with publication: informed consent (secure SharePoint site). This data will be made available to researchers whose proposed use of the data has been approved, for any purpose, upon approval of a proposal with a signed data access agreement (restrictions: none).

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

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

Critical review of the article for significant 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 article approval: 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.

Obtaining 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 assembly: 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.