Nutritional and Contractile Regulation of Muscle Growth
2 other identifiers
interventional
144
1 country
1
Brief Summary
Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent among the elderly and in people who experience periods of physical inactivity and weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence, and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to develop scientifically based treatments that prevent muscle wasting. As one step towards such a goal, this study will examine the physiological and cellular mechanisms that regulate skeletal muscle growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 4, 2017
June 1, 2015
5.9 years
April 29, 2009
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle protein synthesis
Measured during the 8-hour infusion study
Secondary Outcomes (1)
Phosphorylation status of mTOR signaling proteins
Measured during the 8-hour infusion study
Study Arms (14)
Exp 1: AA + Rap
ACTIVE COMPARATORParticipants will receive amino acid supplementation and rapamycin.
Exp 1: AA
PLACEBO COMPARATORParticipants will receive amino acid supplementation and placebo rapamycin.
Exp 1: HEx + Rap
ACTIVE COMPARATORParticipants will receive rapamycin and placebo amino acid supplementation, and they will undergo high-intensity resistance exercise.
Exp 1: HEx
PLACEBO COMPARATORParticipants will receive placebo amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise.
Exp 1: HEx + AA + Rap
ACTIVE COMPARATORParticipants will receive amino acid supplementation and rapamycin, and they will undergo high-intensity resistance exercise.
Exp 1: HEx + AA
PLACEBO COMPARATORParticipants will receive amino acid supplementation and placebo rapamycin, and they will undergo high-intensity resistance exercise.
Exp 2: LExFR + Rap
ACTIVE COMPARATORParticipants will receive rapamycin and will undergo low-intensity resistance exercise with blood flow restriction.
Exp 2 and 3: LExFR
PLACEBO COMPARATORParticipants will receive placebo rapamycin and will undergo low-intensity resistance exercise with blood flow restriction.
Exp 2: SNP
ACTIVE COMPARATORParticipants will receive sodium nitroprusside in a resting state.
Exp 2: FR
ACTIVE COMPARATORParticipants will undergo blood flow restriction in a resting state.
Exp 2: LEx + SNP
ACTIVE COMPARATORParticipants will receive sodium nitroprusside and undergo low-intensity resistance exercise.
Exp 3: LEx
PLACEBO COMPARATORParticipants will undergo low-intensity resistance exercise.
Exp 3: HEx
ACTIVE COMPARATORParticipants will undergo high-intensity resistance exercise.
Exp 3: HEx + AA
ACTIVE COMPARATORParticipants will receive amino acid supplementation and will undergo high-intensity resistance exercise.
Interventions
Single 16-mg oral dose
Nutritional drink containing essential amino acids
Leg extension exercises on a Cybex leg extension machine
Blood flow restriction for 5 minutes after the second biopsy
Eligibility Criteria
You may qualify if:
- to 35 years of age for the young groups
- to 85 years of age for the older groups
- In the follicular phase for the young women participants
- Ability to sign consent form, as based on a score of greater than 25 on the 30-item Mini Mental State Examination (MMSE)
- Stable body weight for at least 1 year
You may not qualify if:
- Physical dependence or frailty, as determined by impairment in any of the activities of daily living (ADLs), history of more than two falls per year, or significant weight loss in the past year
- Exercise training that consists of more than two weekly sessions of moderate to high intensity aerobic or resistance exercise
- Significant heart, liver, kidney, blood, or respiratory disease
- Peripheral vascular disease
- Diabetes mellitus or other untreated endocrine disease
- Active cancer
- History of cancer for participants who may be randomly assigned to rapamycin)
- Acute infectious disease or history of chronic infections (e.g., tuberculosis, hepatitis, HIV, herpes)
- Treatment with anabolic steroids or corticosteroids within 6 months of study entry
- Alcohol or drug abuse
- Tobacco use (smoking or chewing)
- Malnutrition (e.g., body mass index \[BMI\] less than 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
- Obesity (BMI greater than 30 kg/m2)
- Lower than normal hemoglobin levels
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition & Metabolism, University of Texas Medical Branch
Galveston, Texas, 77550, United States
Related Publications (48)
Fujita S, Dreyer HC, Drummond MJ, Glynn EL, Volpi E, Rasmussen BB. Essential amino acid and carbohydrate ingestion before resistance exercise does not enhance postexercise muscle protein synthesis. J Appl Physiol (1985). 2009 May;106(5):1730-9. doi: 10.1152/japplphysiol.90395.2008. Epub 2008 Jun 5.
PMID: 18535123RESULTVolpi E, Chinkes DL, Rasmussen BB. Sequential muscle biopsies during a 6-h tracer infusion do not affect human mixed muscle protein synthesis and muscle phenylalanine kinetics. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E959-63. doi: 10.1152/ajpendo.00671.2007. Epub 2008 Aug 19.
PMID: 18713956RESULTDrummond MJ, Miyazaki M, Dreyer HC, Pennings B, Dhanani S, Volpi E, Esser KA, Rasmussen BB. Expression of growth-related genes in young and older human skeletal muscle following an acute stimulation of protein synthesis. J Appl Physiol (1985). 2009 Apr;106(4):1403-11. doi: 10.1152/japplphysiol.90842.2008. Epub 2008 Sep 11.
PMID: 18787087RESULTDrummond MJ, McCarthy JJ, Fry CS, Esser KA, Rasmussen BB. Aging differentially affects human skeletal muscle microRNA expression at rest and after an anabolic stimulus of resistance exercise and essential amino acids. Am J Physiol Endocrinol Metab. 2008 Dec;295(6):E1333-40. doi: 10.1152/ajpendo.90562.2008. Epub 2008 Sep 30.
PMID: 18827171RESULTDrummond MJ, Fry CS, Glynn EL, Dreyer HC, Dhanani S, Timmerman KL, Volpi E, Rasmussen BB. Rapamycin administration in humans blocks the contraction-induced increase in skeletal muscle protein synthesis. J Physiol. 2009 Apr 1;587(Pt 7):1535-46. doi: 10.1113/jphysiol.2008.163816. Epub 2009 Feb 2.
PMID: 19188252RESULTDrummond MJ, Glynn EL, Fry CS, Dhanani S, Volpi E, Rasmussen BB. Essential amino acids increase microRNA-499, -208b, and -23a and downregulate myostatin and myocyte enhancer factor 2C mRNA expression in human skeletal muscle. J Nutr. 2009 Dec;139(12):2279-84. doi: 10.3945/jn.109.112797. Epub 2009 Oct 14.
PMID: 19828686RESULTDreyer HC, Fujita S, Glynn EL, Drummond MJ, Volpi E, Rasmussen BB. Resistance exercise increases leg muscle protein synthesis and mTOR signalling independent of sex. Acta Physiol (Oxf). 2010 May;199(1):71-81. doi: 10.1111/j.1748-1716.2010.02074.x. Epub 2010 Jan 12.
PMID: 20070283RESULTFry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PMID: 20150565RESULTDrummond MJ, Glynn EL, Fry CS, Timmerman KL, Volpi E, Rasmussen BB. An increase in essential amino acid availability upregulates amino acid transporter expression in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 May;298(5):E1011-8. doi: 10.1152/ajpendo.00690.2009. Epub 2010 Feb 9.
PMID: 20304764RESULTGlynn EL, Fry CS, Drummond MJ, Dreyer HC, Dhanani S, Volpi E, Rasmussen BB. Muscle protein breakdown has a minor role in the protein anabolic response to essential amino acid and carbohydrate intake following resistance exercise. Am J Physiol Regul Integr Comp Physiol. 2010 Aug;299(2):R533-40. doi: 10.1152/ajpregu.00077.2010. Epub 2010 Jun 2.
PMID: 20519362RESULTGlynn EL, Fry CS, Drummond MJ, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Excess leucine intake enhances muscle anabolic signaling but not net protein anabolism in young men and women. J Nutr. 2010 Nov;140(11):1970-6. doi: 10.3945/jn.110.127647. Epub 2010 Sep 15.
PMID: 20844186RESULTDrummond MJ, McCarthy JJ, Sinha M, Spratt HM, Volpi E, Esser KA, Rasmussen BB. Aging and microRNA expression in human skeletal muscle: a microarray and bioinformatics analysis. Physiol Genomics. 2011 May 1;43(10):595-603. doi: 10.1152/physiolgenomics.00148.2010. Epub 2010 Sep 28.
PMID: 20876843RESULTDickinson JM, Fry CS, Drummond MJ, Gundermann DM, Walker DK, Glynn EL, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Mammalian target of rapamycin complex 1 activation is required for the stimulation of human skeletal muscle protein synthesis by essential amino acids. J Nutr. 2011 May;141(5):856-62. doi: 10.3945/jn.111.139485. Epub 2011 Mar 23.
PMID: 21430254RESULTDrummond MJ, Fry CS, Glynn EL, Timmerman KL, Dickinson JM, Walker DK, Gundermann DM, Volpi E, Rasmussen BB. Skeletal muscle amino acid transporter expression is increased in young and older adults following resistance exercise. J Appl Physiol (1985). 2011 Jul;111(1):135-42. doi: 10.1152/japplphysiol.01408.2010. Epub 2011 Apr 28.
PMID: 21527663RESULTFry CS, Drummond MJ, Glynn EL, Dickinson JM, Gundermann DM, Timmerman KL, Walker DK, Dhanani S, Volpi E, Rasmussen BB. Aging impairs contraction-induced human skeletal muscle mTORC1 signaling and protein synthesis. Skelet Muscle. 2011 Mar 2;1(1):11. doi: 10.1186/2044-5040-1-11.
PMID: 21798089RESULTGundermann DM, Fry CS, Dickinson JM, Walker DK, Timmerman KL, Drummond MJ, Volpi E, Rasmussen BB. Reactive hyperemia is not responsible for stimulating muscle protein synthesis following blood flow restriction exercise. J Appl Physiol (1985). 2012 May;112(9):1520-8. doi: 10.1152/japplphysiol.01267.2011. Epub 2012 Feb 23.
PMID: 22362401RESULTWalker DK, Fry CS, Drummond MJ, Dickinson JM, Timmerman KL, Gundermann DM, Jennings K, Volpi E, Rasmussen BB. PAX7+ satellite cells in young and older adults following resistance exercise. Muscle Nerve. 2012 Jul;46(1):51-9. doi: 10.1002/mus.23266. Epub 2012 May 29.
PMID: 22644638RESULTDickinson JM, Drummond MJ, Coben JR, Volpi E, Rasmussen BB. Aging differentially affects human skeletal muscle amino acid transporter expression when essential amino acids are ingested after exercise. Clin Nutr. 2013 Apr;32(2):273-80. doi: 10.1016/j.clnu.2012.07.009. Epub 2012 Aug 1.
PMID: 22889597RESULTFry CS, Drummond MJ, Lujan HL, DiCarlo SE, Rasmussen BB. Paraplegia increases skeletal muscle autophagy. Muscle Nerve. 2012 Nov;46(5):793-8. doi: 10.1002/mus.23423.
PMID: 23055316RESULTFry CS, Drummond MJ, Glynn EL, Dickinson JM, Gundermann DM, Timmerman KL, Walker DK, Volpi E, Rasmussen BB. Skeletal muscle autophagy and protein breakdown following resistance exercise are similar in younger and older adults. J Gerontol A Biol Sci Med Sci. 2013 May;68(5):599-607. doi: 10.1093/gerona/gls209. Epub 2012 Oct 22.
PMID: 23089333RESULTReidy PT, Walker DK, Dickinson JM, Gundermann DM, Drummond MJ, Timmerman KL, Fry CS, Borack MS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Protein blend ingestion following resistance exercise promotes human muscle protein synthesis. J Nutr. 2013 Apr;143(4):410-6. doi: 10.3945/jn.112.168021. Epub 2013 Jan 23.
PMID: 23343671RESULTGlynn EL, Fry CS, Timmerman KL, Drummond MJ, Volpi E, Rasmussen BB. Addition of carbohydrate or alanine to an essential amino acid mixture does not enhance human skeletal muscle protein anabolism. J Nutr. 2013 Mar;143(3):307-14. doi: 10.3945/jn.112.168203. Epub 2013 Jan 23.
PMID: 23343676RESULTDrummond MJ, Dickinson JM, Fry CS, Walker DK, Gundermann DM, Reidy PT, Timmerman KL, Markofski MM, Paddon-Jones D, Rasmussen BB, Volpi E. Bed rest impairs skeletal muscle amino acid transporter expression, mTORC1 signaling, and protein synthesis in response to essential amino acids in older adults. Am J Physiol Endocrinol Metab. 2012 May 15;302(9):E1113-22. doi: 10.1152/ajpendo.00603.2011. Epub 2012 Feb 14.
PMID: 22338078RESULTPaddon-Jones D, Rasmussen BB. Dietary protein recommendations and the prevention of sarcopenia. Curr Opin Clin Nutr Metab Care. 2009 Jan;12(1):86-90. doi: 10.1097/MCO.0b013e32831cef8b.
PMID: 19057193RESULTDrummond MJ, Dreyer HC, Fry CS, Glynn EL, Rasmussen BB. Nutritional and contractile regulation of human skeletal muscle protein synthesis and mTORC1 signaling. J Appl Physiol (1985). 2009 Apr;106(4):1374-84. doi: 10.1152/japplphysiol.91397.2008. Epub 2009 Jan 15.
PMID: 19150856RESULTDickinson JM, Rasmussen BB. Essential amino acid sensing, signaling, and transport in the regulation of human muscle protein metabolism. Curr Opin Clin Nutr Metab Care. 2011 Jan;14(1):83-8. doi: 10.1097/MCO.0b013e3283406f3e.
PMID: 21076294RESULTFry CS, Rasmussen BB. Skeletal muscle protein balance and metabolism in the elderly. Curr Aging Sci. 2011 Dec;4(3):260-8. doi: 10.2174/1874609811104030260.
PMID: 21529326RESULTWalker DK, Dickinson JM, Timmerman KL, Drummond MJ, Reidy PT, Fry CS, Gundermann DM, Rasmussen BB. Exercise, amino acids, and aging in the control of human muscle protein synthesis. Med Sci Sports Exerc. 2011 Dec;43(12):2249-58. doi: 10.1249/MSS.0b013e318223b037.
PMID: 21606874RESULTBell JA, Fujita S, Volpi E, Cadenas JG, Rasmussen BB. Short-term insulin and nutritional energy provision do not stimulate muscle protein synthesis if blood amino acid availability decreases. Am J Physiol Endocrinol Metab. 2005 Dec;289(6):E999-1006. doi: 10.1152/ajpendo.00170.2005. Epub 2005 Jul 19.
PMID: 16030064RESULTBell JA, Volpi E, Fujita S, Cadenas JG, Sheffield-Moore M, Rasmussen BB. Skeletal muscle protein anabolic response to increased energy and insulin is preserved in poorly controlled type 2 diabetes. J Nutr. 2006 May;136(5):1249-55. doi: 10.1093/jn/136.5.1249.
PMID: 16614412RESULTDreyer HC, Fujita S, Cadenas JG, Chinkes DL, Volpi E, Rasmussen BB. Resistance exercise increases AMPK activity and reduces 4E-BP1 phosphorylation and protein synthesis in human skeletal muscle. J Physiol. 2006 Oct 15;576(Pt 2):613-24. doi: 10.1113/jphysiol.2006.113175. Epub 2006 Jul 27.
PMID: 16873412RESULTFujita S, Rasmussen BB, Bell JA, Cadenas JG, Volpi E. Basal muscle intracellular amino acid kinetics in women and men. Am J Physiol Endocrinol Metab. 2007 Jan;292(1):E77-83. doi: 10.1152/ajpendo.00173.2006. Epub 2006 Aug 8.
PMID: 16896165RESULTFujita S, Rasmussen BB, Cadenas JG, Drummond MJ, Glynn EL, Sattler FR, Volpi E. Aerobic exercise overcomes the age-related insulin resistance of muscle protein metabolism by improving endothelial function and Akt/mammalian target of rapamycin signaling. Diabetes. 2007 Jun;56(6):1615-22. doi: 10.2337/db06-1566. Epub 2007 Mar 9.
PMID: 17351147RESULTFujita S, Dreyer HC, Drummond MJ, Glynn EL, Cadenas JG, Yoshizawa F, Volpi E, Rasmussen BB. Nutrient signalling in the regulation of human muscle protein synthesis. J Physiol. 2007 Jul 15;582(Pt 2):813-23. doi: 10.1113/jphysiol.2007.134593. Epub 2007 May 3.
PMID: 17478528RESULTFujita S, Abe T, Drummond MJ, Cadenas JG, Dreyer HC, Sato Y, Volpi E, Rasmussen BB. Blood flow restriction during low-intensity resistance exercise increases S6K1 phosphorylation and muscle protein synthesis. J Appl Physiol (1985). 2007 Sep;103(3):903-10. doi: 10.1152/japplphysiol.00195.2007. Epub 2007 Jun 14.
PMID: 17569770RESULTDreyer HC, Glynn EL, Lujan HL, Fry CS, DiCarlo SE, Rasmussen BB. Chronic paraplegia-induced muscle atrophy downregulates the mTOR/S6K1 signaling pathway. J Appl Physiol (1985). 2008 Jan;104(1):27-33. doi: 10.1152/japplphysiol.00736.2007. Epub 2007 Sep 20.
PMID: 17885021RESULTGlynn EL, Lujan HL, Kramer VJ, Drummond MJ, DiCarlo SE, Rasmussen BB. A chronic increase in physical activity inhibits fed-state mTOR/S6K1 signaling and reduces IRS-1 serine phosphorylation in rat skeletal muscle. Appl Physiol Nutr Metab. 2008 Feb;33(1):93-101. doi: 10.1139/H07-149.
PMID: 18347658RESULTDreyer HC, Drummond MJ, Pennings B, Fujita S, Glynn EL, Chinkes DL, Dhanani S, Volpi E, Rasmussen BB. Leucine-enriched essential amino acid and carbohydrate ingestion following resistance exercise enhances mTOR signaling and protein synthesis in human muscle. Am J Physiol Endocrinol Metab. 2008 Feb;294(2):E392-400. doi: 10.1152/ajpendo.00582.2007. Epub 2007 Dec 4.
PMID: 18056791RESULTDrummond MJ, Glynn EL, Lujan HL, Dicarlo SE, Rasmussen BB. Gene and protein expression associated with protein synthesis and breakdown in paraplegic skeletal muscle. Muscle Nerve. 2008 Apr;37(4):505-13. doi: 10.1002/mus.20976.
PMID: 18236467RESULTDrummond MJ, Fujita S, Abe T, Dreyer HC, Volpi E, Rasmussen BB. Human muscle gene expression following resistance exercise and blood flow restriction. Med Sci Sports Exerc. 2008 Apr;40(4):691-8. doi: 10.1249/MSS.0b013e318160ff84.
PMID: 18317375RESULTDrummond MJ, Bell JA, Fujita S, Dreyer HC, Glynn EL, Volpi E, Rasmussen BB. Amino acids are necessary for the insulin-induced activation of mTOR/S6K1 signaling and protein synthesis in healthy and insulin resistant human skeletal muscle. Clin Nutr. 2008 Jun;27(3):447-56. doi: 10.1016/j.clnu.2008.01.012. Epub 2008 Mar 14.
PMID: 18342407RESULTDrummond MJ, Dreyer HC, Pennings B, Fry CS, Dhanani S, Dillon EL, Sheffield-Moore M, Volpi E, Rasmussen BB. Skeletal muscle protein anabolic response to resistance exercise and essential amino acids is delayed with aging. J Appl Physiol (1985). 2008 May;104(5):1452-61. doi: 10.1152/japplphysiol.00021.2008. Epub 2008 Mar 6.
PMID: 18323467RESULTDreyer HC, Drummond MJ, Glynn EL, Fujita S, Chinkes DL, Volpi E, Rasmussen BB. Resistance exercise increases human skeletal muscle AS160/TBC1D4 phosphorylation in association with enhanced leg glucose uptake during postexercise recovery. J Appl Physiol (1985). 2008 Dec;105(6):1967-74. doi: 10.1152/japplphysiol.90562.2008. Epub 2008 Oct 9.
PMID: 18845784RESULTDrummond MJ, Rasmussen BB. Leucine-enriched nutrients and the regulation of mammalian target of rapamycin signalling and human skeletal muscle protein synthesis. Curr Opin Clin Nutr Metab Care. 2008 May;11(3):222-6. doi: 10.1097/MCO.0b013e3282fa17fb.
PMID: 18403916RESULTBorack MS, Dickinson JM, Fry CS, Reidy PT, Markofski MM, Deer RR, Jennings K, Volpi E, Rasmussen BB. Effect of the lysosomotropic agent chloroquine on mTORC1 activation and protein synthesis in human skeletal muscle. Nutr Metab (Lond). 2021 Jun 12;18(1):61. doi: 10.1186/s12986-021-00585-w.
PMID: 34118944DERIVEDGraber TG, Borack MS, Reidy PT, Volpi E, Rasmussen BB. Essential amino acid ingestion alters expression of genes associated with amino acid sensing, transport, and mTORC1 regulation in human skeletal muscle. Nutr Metab (Lond). 2017 May 11;14:35. doi: 10.1186/s12986-017-0187-1. eCollection 2017.
PMID: 28503190DERIVEDDickinson JM, Gundermann DM, Walker DK, Reidy PT, Borack MS, Drummond MJ, Arora M, Volpi E, Rasmussen BB. Leucine-enriched amino acid ingestion after resistance exercise prolongs myofibrillar protein synthesis and amino acid transporter expression in older men. J Nutr. 2014 Nov;144(11):1694-702. doi: 10.3945/jn.114.198671. Epub 2014 Sep 3.
PMID: 25332468DERIVEDDickinson JM, Drummond MJ, Fry CS, Gundermann DM, Walker DK, Timmerman KL, Volpi E, Rasmussen BB. Rapamycin does not affect post-absorptive protein metabolism in human skeletal muscle. Metabolism. 2013 Jan;62(1):144-51. doi: 10.1016/j.metabol.2012.07.003. Epub 2012 Sep 6.
PMID: 22959478DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Blake Rasmussen, PhD
The University of Texas Medical Branch, Galveston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2009
First Posted
May 1, 2009
Study Start
April 1, 2009
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 4, 2017
Record last verified: 2015-06
Data Sharing
- IPD Sharing
- Will not share