Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequentiy associated with chronic nausea and vomiting, eariy satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. The broad objectives of this proposal is to improve our understanding ofthls disorder and advancing the diagnosis and treatment of gastroparesis and related disorders. We propose to do this through three specific aims, as follows:
Specific Aim 1 : To complete ongoing and approved studies initiated by the NIH-funded GpCRC (the Gastroparesis Clinical Research Consortium, a collaboration between six clinical sites and data coordinating center). These include (1) a randomized trial of nortriptyline vs. placebo for idiopathic gastroparesis, (2) a pilot study of safety, feasibility and potential efficacy of continuous glucose monitoring and insulin pump therapy in diabetic gastroparesis, (3) a randomized trial of aprepitant vs. placebo for the relief of nausea in patients with chronic nausea and vomiting of presumed gastric origin and (4) a tissue study from full thickness gastric biopsies.
Specific Aim 2 : To maintain, expand, and refine the Gastroparesis Registry (ClinicalTrials.gov NCT00398801) in order to enable critical additional analyses of the clinical data and biosamples. The first Registry patient with gastroparesis was recruited in February 2007 and a total of 587 patients were enrolled by end of recruitment in March 2010.
Our aim i s to have at least four years of follow-up on all patients and with up to 9 years for some patients. This will require maintenance of the Registry and continued periodic follow-up visits over the next five years.
Specific Aim 3 : To understand nitrergic control of gastric sensorimotor function: correlation with gender, diabetes and gastric emptying phenotype in patients with gastroparesis and chronic unexplained nausea and vomiting.

Public Health Relevance

Gastroparesis has a devastating impact on quality of life and predominantly affects younger women. This research will help find new ways to diagnose and treat this condition as well as related disorders characterized by nausea and vomiting.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
7U01DK073983-07
Application #
8327159
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (J2))
Program Officer
Hamilton, Frank A
Project Start
2006-04-15
Project End
2016-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
7
Fiscal Year
2012
Total Cost
$476,621
Indirect Cost
$36,062
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Bernard, C E; Gibbons, S J; Mann, I S et al. (2014) Association of low numbers of CD206-positive cells with loss of ICC in the gastric body of patients with diabetic gastroparesis. Neurogastroenterol Motil 26:1275-84
Parkman, Henry P; Yates, Katherine; Hasler, William L et al. (2013) Cholecystectomy and clinical presentations of gastroparesis. Dig Dis Sci 58:1062-73
Hasler, W L; Wilson, L A; Parkman, H P et al. (2013) Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil 25:427-38, e300-1
Parkman, Henry P; Van Natta, Mark L; Abell, Thomas L et al. (2013) Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA 310:2640-9
Iorio, Raffaele; Lucchinetti, Claudia F; Lennon, Vanda A et al. (2013) Intractable nausea and vomiting from autoantibodies against a brain water channel. Clin Gastroenterol Hepatol 11:240-5
Grover, M; Bernard, C E; Pasricha, P J et al. (2012) Clinical-histological associations in gastroparesis: results from the Gastroparesis Clinical Research Consortium. Neurogastroenterol Motil 24:531-9, e249
Pasricha, Pankaj J; Colvin, Ryan; Yates, Katherine et al. (2011) Characteristics of patients with chronic unexplained nausea and vomiting and normal gastric emptying. Clin Gastroenterol Hepatol 9:567-76.e1-4
Parkman, Henry P; Yates, Katherine P; Hasler, William L et al. (2011) Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis. Gastroenterology 141:486-98, 498.e1-7
Parkman, Henry P; Yates, Katherine; Hasler, William L et al. (2011) Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology 140:101-15
Mazzone, Amelia; Bernard, Cheryl E; Strege, Peter R et al. (2011) Altered expression of Ano1 variants in human diabetic gastroparesis. J Biol Chem 286:13393-403

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