This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Crohn's disease is a chronic inflammatory condition of unknown etiology affecting all aspects of the gastrointestinal tract. Current treatment offers no cure and comes at the expense of multiple side effects; therefore, research to identify more effective therapies is needed. The possibility of recombinant human growth hormone (GH) as a treatment has received attention recently. Results from a preliminary study using GH and a high protein diet in patients with Crohn's disease suggest that GH may be beneficial in the treatment of these patients^1. Growth hormone release hormone (GHRH), a peptide that stimulates the synthesis and secretion of growth hormone from the somatotrope cells of the anterior pituitary gland, is also naturally found in the gut. It is not known if GHRH has local actions in the gut. We hypothesize that treatment with human growth hormone or growth hormone releasing hormone will be beneficial to patients with Crohn's disease by decreasing disease severity, improving growth, and increasing bone mineral density. GHRH may have added benefit if it acts locally in the gut. The purpose of this study is to test our hypothesis in a prospective, randomized, double blind clinical trial. After a 6-month observation period, patients will be randomized to one of three groups to receive daily injections of GH (drug), GEREF (GHRH analog), or diluent (placebo) for a period of 6 months. The primary end point to be measured is the change in the Crohn's disease activity index (CDAI), which assesses the severity of disease using clinical and laboratory criteria.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000750-34
Application #
7379066
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
34
Fiscal Year
2006
Total Cost
$10,222
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
Zillikens, M Carola; Demissie, Serkalem; Hsu, Yi-Hsiang et al. (2017) Large meta-analysis of genome-wide association studies identifies five loci for lean body mass. Nat Commun 8:80
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Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Robarge, Jason D; Desta, Zereunesay; Nguyen, Anne T et al. (2017) Effects of exemestane and letrozole therapy on plasma concentrations of estrogens in a randomized trial of postmenopausal women with breast cancer. Breast Cancer Res Treat 161:453-461
Hertz, Daniel L; Speth, Kelly A; Kidwell, Kelley M et al. (2017) Variable aromatase inhibitor plasma concentrations do not correlate with circulating estrogen concentrations in post-menopausal breast cancer patients. Breast Cancer Res Treat 165:659-668

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