Sabrina Paganoni1,2,3, Theodore Hyman4, Amy Shui5, Peggy Allred4, Matthew Harms4, Jingxia Liu4, Nicholas Maragakis6, David Schoenfeld5, Hong Yu1, Nazem Atassi1, Merit Cudkowicz1, Timothy M Miller4. 1. Neurological Clinical Research Institute, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA. 2. Department of Physical Medicine and Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, Massachusetts, USA. 3. VA Healthcare System, Boston, Massachusetts, USA. 4. Department of Neurology, Washington University School of Medicine, 115 Biotech Building, Box 8111, 660 South Euclid, Street, St. Louis, Missouri, 63110, USA. 5. Massachusetts General Hospital Biostatistics Center, Boston, Massachusetts, USA. 6. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Abstract
INTRODUCTION: The aim of this study was to determine whether a history of pre-morbid type 2 diabetes mellitus (DM2) is a prognostic factor in amyotrophic lateral sclerosis (ALS). METHODS: The relationship between DM2 and survival was analyzed in a study population consisting of 1,322 participants from 6 clinical trials. RESULTS: Survival did not differ by diabetes status (log-rank test, P = 0.98), but did differ by body mass index (BMI) (log-rank test, P = 0.008). In multivariate analysis, there was no significant association between diabetes and survival (P = 0.18), but the risk of reaching a survival endpoint decreased by 4% for each unit increase in baseline BMI (HR 0.96, 95% CI 0.94-0.99, P = 0.001). DM2 was less prevalent among ALS clinical trial participants than predicted. CONCLUSIONS: A history of pre-morbid DM2 is not an independent prognostic factor in ALS clinical trial databases. The low DM2 prevalence rate should be examined in a large, prospective study to determine whether DM2 affects ALS risk.
INTRODUCTION: The aim of this study was to determine whether a history of pre-morbid type 2 diabetes mellitus (DM2) is a prognostic factor in amyotrophic lateral sclerosis (ALS). METHODS: The relationship between DM2 and survival was analyzed in a study population consisting of 1,322 participants from 6 clinical trials. RESULTS: Survival did not differ by diabetes status (log-rank test, P = 0.98), but did differ by body mass index (BMI) (log-rank test, P = 0.008). In multivariate analysis, there was no significant association between diabetes and survival (P = 0.18), but the risk of reaching a survival endpoint decreased by 4% for each unit increase in baseline BMI (HR 0.96, 95% CI 0.94-0.99, P = 0.001). DM2 was less prevalent among ALS clinical trial participants than predicted. CONCLUSIONS: A history of pre-morbid DM2 is not an independent prognostic factor in ALS clinical trial databases. The low DM2 prevalence rate should be examined in a large, prospective study to determine whether DM2 affects ALS risk.
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