Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin|
- Zonulin concentration in serum (ng/mg) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Participants will undergo a one-time blood draw in order to test for zonulin concentration in serum (ng/mg) and these results will be compared to normative data to screen for elevations. The sample size for this pilot study was estimated based on the known prevalence of Celiac disease in schizophrenia, a disease known to have elevated zonulin levels.
Biospecimen Retention: Samples With DNA
Zonulin and gliadin antibodies will be sent to the lab of Dr. Alessio Fasano for assay.
Genetic and Biochemical analysis will be sent for analysis and storage of blood sample at the Maryland Psychiatric Research Center Neurogenetics laboratory under the direction of Dr. Ikwunga Wonodi. Analysis will include kynurenic acid metabolites, inflammatory markers from Peripheral Blood Mononuclear Cells (PBMC) and future genetic analysis including but not limited to human leukocyte antigen (HLA) haplotypes (DQ2 and DQ8).
Cytokines will be analyzed by the Cytokine Core Laboratory at the University of Maryland using Luminex Technology.
Other standard laboratories will be done by Lab Corp or other contract laboratory.
|Study Start Date:||July 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558570
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||Deanna L. Kelly, Pharm.D., BCPP||University of Maryland|