Abstract

This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study is an open-label extension of AALS-001 in those patients who completed 12 weeks of treatment and the Week 16 Follow-up Visit. Subjects will receive 100 mg tid arimoclomol daily for approximately six months. Visits will occur at Screening, Baseline, and once a month for six months (total of 8 visits). A telephone call follow-up at Month 7 will end subject participation in the study. The primary purpose of this study is to identify safety problems with long-term use. If half the patients participate there will be 40 patients on this study and we will have over an 80% chance of seeing at least one occurrence of any side effect that occurs with a frequency of over 4%.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001066-30
Application #
7607085
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-12-01
Project End
2007-11-30
Budget Start
2006-12-01
Budget End
2007-11-30
Support Year
30
Fiscal Year
2007
Total Cost
$12,217
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code

  Publications

Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Srinivasa, Suman; Lu, Michael T; Fitch, Kathleen V et al. (2018) Epicardial adipose tissue volume and cardiovascular risk indices among asymptomatic women with and without HIV. Antivir Ther 23:1-9
Schorr, Melanie; Dichtel, Laura E; Gerweck, Anu V et al. (2018) Sex differences in body composition and association with cardiometabolic risk. Biol Sex Differ 9:28
Srinivasan, Shylaja; Kaur, Varinderpal; Chamarthi, Bindu et al. (2018) TCF7L2 Genetic Variation Augments Incretin Resistance and Influences Response to a Sulfonylurea and Metformin: The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH). Diabetes Care 41:554-561
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Fourman, Lindsay T; Czerwonka, Natalia; Shaikh, Sofia D et al. (2018) Insulin-like growth factor 1 inversely relates to monocyte/macrophage activation markers in HIV. AIDS 32:927-932
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44

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