Association Between Change in Body Mass Index, Unified Parkinson’s Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease :  Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1

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Abstract

IMPORTANCE

Greater body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) is associated with improved survival among persons with Huntington disease or amyotrophic lateral sclerosis. Weight loss is common among persons with Parkinson disease (PD) and is associated with worse quality of life.

OBJECTIVE

To explore the association between change in BMI, Unified Parkinson’s Disease Rating Scale (UPDRS) motor and total scores, and survival among persons with PD and to test whether there is a positive association between BMI at randomization and survival.

DESIGN, SETTING, AND PARTICIPANTS

Secondary analysis (from May 27, 2014, to October 13, 2015) of longitudinal data (3–6 years) from 1673 participants who started the National Institute of Neurological Disorders and Stroke Exploratory Trials in PD Long-term Study-1 (NET-PD LS-1). This was a double-blind randomized placebo-controlled clinical trial of creatine monohydrate (10 g/d) that was performed at 45 sites throughout the United States and Canada. Participants with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) PD were enrolled from March 2007 to May 2010 and followed up until September 2013.

MAIN OUTCOMES AND MEASURES

Change across time in motor UPDRS score, change across time in total UPDRS score, and time to death. Generalized linear mixed models were used to estimate the effect of BMI on the change in motor and total UPDRS scores after controlling for covariates. Survival was analyzed using Cox proportional hazards models of time to death. A participant’s BMI was measured at randomization, and BMI trajectory groups were classified according to whether participants experienced weight loss (“decreasing BMI”), weight stability (“stable BMI”), or weight gain (“increasing BMI”) during the study.

RESULTS

Of the 1673 participants (mean [SD] age, 61.7 [9.6] years; 1074 [64.2%] were male), 158 (9.4%) experienced weight loss (decreasing BMI), whereas 233 (13.9%) experienced weight gain (increasing BMI). After adjusting for covariates, we found that the weight-loss group’s mean (SE) motor UPDRS score increased by 1.48 (0.28) ( P < .001) more points per visit than the weight-stable group’s mean (SE) motor UPDRS score. The weight-gain group’s mean (SE) motor UPDRS score decreased by −0.51 (0.24) ( P = .03) points per visit, relative to the weight-stable group. While there was an unadjusted difference in survival between the 3 BMI trajectory groups (log-rank P < .001), this was not significant after adjusting for covariates.

CONCLUSIONS AND RELEVANCE

Change in BMI was inversely associated with change in motor and total UPDRS scores in the NET-PD LS-1. Change in BMI was not associated with survival; however, these results were limited by the low number of deaths in the NET-PD LS-1.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00449865

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Author and article information

Journal

Journal ID (nlm-journal-id): 101589536

Journal ID (pubmed-jr-id): 40865

Journal ID (nlm-ta): JAMA Neurol

Journal ID (iso-abbrev): JAMA Neurol

Title: JAMA neurology

ISSN (Print): 2168-6149

ISSN (Electronic): 2168-6157

Publication date Nihms-submitted: 12 April 2017

Publication date (Print): March 2016

Publication date PMC-release: 13 June 2017

Volume: 73

Issue: 3

Pages: 321-328

Affiliations

Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston (Wills); Department of Biostatistics, The University of Texas Health Science Center at Houston UTHealth, School of Public Health, Austin (Pérez); UTHealth, The University of Texas School of Public Health, Houston (Wang, Su); Department of Neurology, Medical College of Georgia, Georgia Regents University, Augusta (Morgan); Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston UTHealth, School of Public Health, Houston. (Rajan); Department of Neurology, University of Colorado Hospital and University of Colorado School of Medicine, Aurora (Leehey); Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, Maryland (Pontone); Departments of Neurology and Neurosurgery, University of Michigan, Ann Arbor (Chou); Department of Neurology, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts (Umeh); Department of Neurology, Johns Hopkins University, Baltimore, Maryland (Mari); Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (Boyd)

Author notes

Corresponding Author: Anne-Marie A. Wills, MD, MPH, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, 55 Fruit St, Wang Ambulatory Care Center, Room 715, Boston, MA 02114 ( awills@ 123456partners.org )

Group Information: NET-PD Steering Committee: Karl Kieburtz, MD, MPH (principal investigator, coordination center), University of Rochester, Rochester, New York; Barbara Tilley, PhD (principal investigator, statistical center), University of Texas, Houston; Debra Babcock, PhD, MD, and Wendy Galpern, MD, PhD, NIH, Bethesda, Maryland; Robert Hauser, MD, University of South Florida, Tampa; Connie Kawai, RN, BSN, CCRC, University of Southern California, Los Angeles; Brad A. Racette, MD, Washington University School of Medicine, St Louis, Missouri; Bernard Ravina, MD, MSCE, Voyager Therapeutics Inc, Cambridge, Massachusetts; Sue Reichwein, CCRC, University of Pennsylvania, Philadelphia; G. Webster Ross, MD, Pacific Health Research and Education Institute, Honolulu, Hawaii; Kathleen M. Shannon, MD, Rush University Medical Center, Chicago, Illinois; Oksana Suchowersky, MD, University of Calgary, Alberta, Canada; CarolineM. Tanner, MD, PhD, The Parkinson’s Institute, Sunnyvale, California; Jessie Tatsuno Roth, RN, BSN, University of California San Francisco. NET-PD Statistical Center (University of Texas Health Science Center at Houston) : Keith Burau, PhD; Jordan Elm, PhD; Rong Ye, MS; and Adriana Pérez, MS, PhD. NET-PD Clinical Trials Coordination Center Staff (University of Rochester, Rochester, New York) : Debbie Baker, AAS; Liana Baker, MPH; Susan Bennett, AAS; Lisa DeBlieck, MPA, CCRC; Debbie Frasier, BS; Irenita Gardiner, RN; Jennifer Harman, PhD, CCRP, CCRC; Cornelia Kamp, MBA; Laith Khadim, MD; Gina Lau, BS; Beverly Olsen, BA; Saloni Sharma, MD; David Shprecher DO; Ann Stoutenburg, CCRC; Christine Weaver, CCRP; and Renee Wilson, MA. NET-PD Consultants : Christopher Goetz, MD, Rush University Medical Center, Chicago, Illinois; David Ploth, MD, Medical University of South Carolina, Charleston. Data and Safety Monitoring Board: Cynthia R. Gross, PhD (chair), University of Minnesota, Minneapolis; Karen L. Bell, MD, Columbia University, New York, New York; Donna T. Chen, MD, MPH, University of Virginia Health System, Charlottesville; Robert Foley, MD, United States Renal Data System Coordinating Center, Minneapolis, Minnesota; David E. Levy, MD, Weill Cornell Medical College, New York, New York; Robert L. Rodnitzky, MD, University of Iowa College of Medicine, Iowa City. Oversight Board: K. Michael Welch, MD (chair), Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; M. Flint Beal, MD, Weill Medical College of Cornell University, New York, New York; Jeffrey L. Cummings, MD, University of California, Los Angeles, Alzheimer Disease Center; Diane DiEuliis, PhD, Health and Human Services, Washington, DC; David J. Edwards, PharmD, Wayne State University, Detroit, Michigan; Stanley Fahn, MD, and Bruce Levin, PhD, Columbia University, New York, New York; Russell G. Katz, MD, US Food and Drug Administration, Rockville, Maryland; Deborah B. Marin, MD, and C. Warren Olanow, MD, Mount Sinai School of Medicine, New York, New York; Jeffrey C. Martin, Esq, Goodwin Proctor LLP, Rockville, Maryland; Steven Piantadosi, MD, PhD, Cedars-Sinai Medical Center, Los Angeles, California; William J. Powers, MD, University of North Carolina School of Medicine, Chapel Hill; Alison Wichman, MD, NIH, Bethesda, Maryland. NIH (NINDS, Bethesda, Maryland) : Debra Babcock, PhD, MD; Wendy Galpern, MD, PhD; John Marler, MD; Claudia Moy, PhD; Joanne Odenkirchen, MPH.

Article

Accession ID: PMC5469290 Pmcid ID: PMC5469290 Pmc-uid ID: 5469290 Manuscript ID: nihpa863816

DOI: 10.1001/jamaneurol.2015.4265

PMC ID: 5469290

PubMed ID: 26751506

SO-VID: a53ca5d3-f604-4455-adbf-e06d48d88630

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Association Between Change in Body Mass Index, Unified Parkinson’s Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease : Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1

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