Effects of Hypoxia and Inflammation on Citrulline Synthesis by Ornithine Transcarbamylase in Human Enterocytes
HYPOCITRE
1 other identifier
interventional
30
1 country
1
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic systemic hypoxia and low-grade inflammation as well as by an alteration of arginine (ARG) metabolism. As ARG is synthetized from circulating citrulline (CIT), an alteration of CIT homeostasis, particularly its production by ornithine transcarbamylase (OCT) in small intestine could be involved. We hypothesized that hypoxia +/- inflammation, classically associated to COPD, has effects on OCT regulation in enterocytes. This study aims at exploring the effects of hypoxia and inflammation on the production of citrulline by ornithine transcarbamylase (OTC) activity in enterocytes from explant cultures of duodenal tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
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
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedDecember 6, 2016
December 1, 2016
1 year
June 28, 2016
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
OCT activity in biopsy specimens
OCT activity in duodenal biopsy specimens will be measured at the end of the incubation period and compared between the 4 different groups (standard/inflammatory/hypoxic:inflammatory+hypoxic conditions)
OCT activity in biopsies after incubation
Study Arms (1)
only one arm
OTHERPatients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed.
Interventions
Patients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed.
Eligibility Criteria
You may qualify if:
- Digestive disease known or suspected which justify an oeso-gastro-endoscopy with digestive biopsies, excepted a disease with duodenal localization known or strongly suspected.
- Gastroscopy performed under general anaesthesia
- Patient's written agreement obtained
- Age \< 18
- Therapeutical endoscopy (that is to say when a therapeutical act will be performed as balloon dilation, digestive or biliary prosthesis, drainage, diverticulotomy, polypectomy, variceal ligation...) either expected or
- Duodenal pathology (known or strongly suspected with the clinical and biological elements)
- Duodenal biopsies are not allowed to be performed: vascular lesions, digestive haemorrhage, clotting disorder.
- Antiplatelet drug and anticoagulant drug
- Lack of written agreement
- Subjects hospitalized in an emergency state or without agreement
- Subjects who cannot be contacted in emergency.
You may not qualify if:
- subjects will be excluded from the study:
- if an unexpected therapeutic act has to be performed during the endoscopy
- if duodenal duodenal atrophy or lesions are discovered during the endoscopy
- if duodenal lesions are discoverd at the histological examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- AGIR à Domcollaborator
Study Sites (1)
Grenoble University Hospital
Grenoble, 38043, France
Related Publications (31)
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PMID: 22568979BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Fontaine, Professor
Division of clinical Nutrition-Grenoble University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
June 30, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
December 6, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share