Title {1} | Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial |
Trial registration {2a and 2b}. | ClinicalTrials.gov registry: https://clinicaltrials.gov/ct2/show/NCT03675360. Registered on September 18, 2018. |
Protocol version {3} | Version 2.2, Date: September 14, 2020 |
Funding {4} | This work was supported by the National Institute of General Medical Sciences (grant 1P20GM109036-01A1). |
Author details {5a} |
Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA Kirsten S. Dorans, Lydia A. Bazzano, Lu Qi, Hua He, Jing Chen, Katherine T. Mills, Bernadette T. Nguyen, Jiang He Department of Medicine, Tulane University School of Medicine, New Orleans, LA Lydia A. Bazzano, Jing Chen, Jiang He Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD Lawrence J. Appel Colorado School of Public Health, Aurora, Colorado Jonathan M. Samet Division of General Internal Medicine and Geriatrics, Department of Medicine; Institute of Public Health and Medicine; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA Matthew J. O’Brien Department of Endocrinology, Diabetes, Metabolism, and Weight Management, Ochsner Medical Center, New Orleans, Louisiana Gabriel I. Uwaifo |
Name and contact information for the trial sponsor {5b} |
Kirsten S. Dorans, ScD Department of Epidemiology Tulane University School of Public Health and Tropical Medicine 1440 Canal St, Suite 2000, New Orleans, LA 70112 Phone: 504.988.0883 Email: kdorans@tulane.edu |
Role of sponsor {5c} | The investigators are responsible for study design, collection, management, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. |