HypoxiaHYPOCITRENCT02820064
Effects of Hypoxia and Inflammation on Citrulline Synthesis by Ornithine Transcarbamylase in Human Enterocytes
A study testing duodenal biopsy during gastroduodenal endoscopy in people with Hypoxia and Inflammation, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Inflammation, Chronic Obstructive Pulmonary Disease
- What is being tested?
- duodenal biopsy during gastroduodenal endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Non inclusion-criteria:
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Eric FONTAINE, Professor contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38043
Eric Fontaine, Professor
Patrick Tuvignon, MD
About this study
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.
Read the detailed description
Citrulline is an amino-acid almost exclusively released by the small intestine after its synthesis from glutamine by the OTC in enterocytes. Citrulline from the small intestine is released into the portal vena and, because it does not enter hepatocytes, it reaches the systemic circulation to be metabolized in arginine by kidneys. By this way, is an important source of endogenous ARG. Moreover, evidence suggests that circulating citrulline could have a direct action on the regulation of muscle protein synthesis. Therefore, the administration of citrulline might be an interesting nutritional strategy to preserve or restore muscle mass and function. Muscle mass is a determinant of respiratory function and muscle weakness explains for a large part morbidity and mortality in patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
Evidence suggests that citrulline plasmatic levels would be lower in several states involving systemic inflammation and hypoxia. Indeed, it has been observed in rats that hypoxia leads to a sharp decline in plasma CIT concentration and also in human (hypocitrullinemia has been observed in Intensive Care Unit patients and in subjects suffering from sepsis and trauma) but the cause of relationship is not yet established. Therefore, it may be supposed that a decreased plasma CIT level could be responsible for a decrease in de novo ARG synthesis leading to an impairment of NO production (endothelial dysfunction) in these pathological situations.
Because chronic hypoxia and systemic inflammation are both systemic traits of patients suffering from COPD, the fact that hypoxia and/or systemic inflammation might directly affect OCT, decreasing intestinal citrulline production which, in turn, could contribute to endothelial dysfunction and muscle weakness is considered.
In order to explore this hypothesis, the potential consequences of hypoxia and inflammation (alone or in association) on citrulline synthesis by the OCT in human enterocytes will be determined, thanks to an "explant" culture model of duodenal tissue. Duodenal biopsies will be removed during oesophago-gastro-duodenoscopies performed in the Hepato-gastro-enterology unit of Grenoble University Hospital, among patients expected to undergo a gastroscopy for any diagnostic purpose. 30 patients will be selected during a period of 6 months. After complete information and written agreement, 8 biopsy specimens will be removed from the duodenum of each patient and processed for organ culture.
Then, duodenal biopsies will be incubated in the presence or not of cytokines and exposed or not to hypoxia. Indeed, 4 groups will be constituted: a control group (no stimulus), a group exposed to hypoxic conditions, a group exposed to inflammatory conditions (cytokines) and a group exposed to both hypoxic an inflammatory conditions.
As primary endpoint, for each group, the OTC activity and the citrulline production in the culture medium will be studied.
- Conditions
- Hypoxia, Inflammation, Chronic Obstructive Pulmonary Disease
- Being tested
- duodenal biopsy during gastroduodenal endoscopy
- Medical subject headings
- Hypoxia, Inflammation, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal biopsy during gastroduodenal endoscopyProcedure or surgery
Patients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed.
| Study group | Role | What they receive |
|---|---|---|
| only one arm | Other | Patients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed. Receives: Procedure: duodenal biopsy during gastroduodenal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: OCT activity in biopsies after incubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Eric Fontaine, Professor, Principal investigator, Division of clinical Nutrition-Grenoble University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820064
- Sponsor's protocol ID
- 38RC15.303
- Acronym
- HYPOCITRE
- Status last verified
- Dec 2016
- First submitted
- 28 Jun 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moinard C, Cynober L. Citrulline: a new player in the control of nitrogen homeostasis. J Nutr. 2007 Jun;137(6 Suppl 2):1621S-1625S. doi: 10.1093/jn/137.6.1621S.
PubMed 17513438Windmueller HG, Spaeth AE. Source and fate of circulating citrulline. Am J Physiol. 1981 Dec;241(6):E473-80. doi: 10.1152/ajpendo.1981.241.6.E473.
PubMed 7325229Breuillard C, Cynober L, Moinard C. Citrulline and nitrogen homeostasis: an overview. Amino Acids. 2015 Apr;47(4):685-91. doi: 10.1007/s00726-015-1932-2. Epub 2015 Feb 13.
PubMed 25676932Osowska S, Moinard C, Neveux N, Loi C, Cynober L. Citrulline increases arginine pools and restores nitrogen balance after massive intestinal resection. Gut. 2004 Dec;53(12):1781-6. doi: 10.1136/gut.2004.042317.
PubMed 15542514Osowska S, Duchemann T, Walrand S, Paillard A, Boirie Y, Cynober L, Moinard C. Citrulline modulates muscle protein metabolism in old malnourished rats. Am J Physiol Endocrinol Metab. 2006 Sep;291(3):E582-6. doi: 10.1152/ajpendo.00398.2005. Epub 2006 Apr 11.
PubMed 16608884Faure C, Raynaud-Simon A, Ferry A, Dauge V, Cynober L, Aussel C, Moinard C. Leucine and citrulline modulate muscle function in malnourished aged rats. Amino Acids. 2012 Apr;42(4):1425-33. doi: 10.1007/s00726-011-0841-2. Epub 2011 Feb 23.
PubMed 21344178Faure C, Morio B, Chafey P, Le Plenier S, Noirez P, Randrianarison-Huetz V, Cynober L, Aussel C, Moinard C. Citrulline enhances myofibrillar constituents expression of skeletal muscle and induces a switch in muscle energy metabolism in malnourished aged rats. Proteomics. 2013 Jul;13(14):2191-201. doi: 10.1002/pmic.201200262. Epub 2013 Jun 10.
PubMed 23592530Ventura G, Noirez P, Breuille D, Godin JP, Pinaud S, Cleroux M, Choisy C, Le Plenier S, Bastic V, Neveux N, Cynober L, Moinard C. Effect of citrulline on muscle functions during moderate dietary restriction in healthy adult rats. Amino Acids. 2013 Nov;45(5):1123-31. doi: 10.1007/s00726-013-1564-3. Epub 2013 Aug 3.
PubMed 23913268The economic burden of lung disease. European white lung book 2013:16-27.
Antonione R. Nutrition in cardiac and pulmonary disease. In Basic in clinical nutrition. Sobotka L. ed. Galen, 4th ed. 485-493.
Jonker R. and al. Whole body de novo ARG production and NO synthesis are reduced in COPD patients. Clin.Nutr. 2013;32(S1):S5-S6.
Coeffier M, Miralles-Barrachina O, Le Pessot F, Lalaude O, Daveau M, Lavoinne A, Lerebours E, Dechelotte P. Influence of glutamine on cytokine production by human gut in vitro. Cytokine. 2001 Feb 7;13(3):148-54. doi: 10.1006/cyto.2000.0813.
PubMed 11161457Lecleire S, Coeffier M, Leblond J, Hubert A, Lemoulan S, Petit A, Ducrotte P, Dechelotte P, Marion R. Modulation of nitric oxide and cytokines production by L-arginine in human gut mucosa. Clin Nutr. 2005 Jun;24(3):353-9. doi: 10.1016/j.clnu.2004.11.011.
PubMed 15896421Hubert-Buron A, Leblond J, Jacquot A, Ducrotte P, Dechelotte P, Coeffier M. Glutamine pretreatment reduces IL-8 production in human intestinal epithelial cells by limiting IkappaBalpha ubiquitination. J Nutr. 2006 Jun;136(6):1461-5. doi: 10.1093/jn/136.6.1461.
PubMed 16702304Reimund JM, Wittersheim C, Dumont S, Muller CD, Kenney JS, Baumann R, Poindron P, Duclos B. Increased production of tumour necrosis factor-alpha interleukin-1 beta, and interleukin-6 by morphologically normal intestinal biopsies from patients with Crohn's disease. Gut. 1996 Nov;39(5):684-9. doi: 10.1136/gut.39.5.684.
PubMed 9026483
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypoxia and Inflammation on Citrulline Synthesis by Ornithine Transcarbamylase in Human Enterocytes
- ClinicalTrials.gov ID
- NCT02820064
- Acronym / sponsor ID
- HYPOCITRE / 38RC15.303
- Conditions
- Hypoxia, Inflammation, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Citrulline is an amino-acid almost exclusively released by the small intestine after its synthesis from glutamine by the OTC in enterocytes. Citrulline from the small intestine is released into the portal vena and, because it does not enter hepatocytes, it reaches the systemic circulation to be metabolized in arginine by kidneys. By this way, is an important source of endogenous ARG. Moreover, evidence suggests that circulating citrulline could have a direct action on the regulation of muscle protein synthesis. Therefore, the administration of citrulline might be an interesting nutritional strategy to preserve or restore muscle mass and function. Muscle mass is a determinant of respiratory function and muscle weakness explains for a large part morbidity and mortality in patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
Evidence suggests that citrulline plasmatic levels would be lower in several states involving systemic inflammation and hypoxia. Indeed, it has been observed in rats that hypoxia leads to a sharp decline in plasma CIT concentration and also in human (hypocitrullinemia has been observed in Intensive Care Unit patients and in subjects suffering from sepsis and trauma) but the cause of relationship is not yet established. Therefore, it may be supposed that a decreased plasma CIT level could be responsible for a decrease in de novo ARG synthesis leading to an impairment of NO production (endothelial dysfunction) in these pathological situations.
Because chronic hypoxia and systemic inflammation are both systemic traits of patients suffering from COPD, the fact that hypoxia and/or systemic inflammation might directly affect OCT, decreasing intestinal citrulline production which, in turn, could contribute to endothelial dysfunction and muscle weakness is considered.
In order to explore this hypothesis, the potential consequences of hypoxia and inflammation (alone or in association) on citrulline synthesis by the OCT in human enterocytes will be determined, thanks to an "explant" culture model of duodenal tissue. Duodenal biopsies will be removed during oesophago-gastro-duodenoscopies performed in the Hepato-gastro-enterology unit of Grenoble University Hospital, among patients expected to undergo a gastroscopy for any diagnostic purpose. 30 patients will be selected during a period of 6 months. After complete information and written agreement, 8 biopsy specimens will be removed from the duodenum of each patient and processed for organ culture.
Then, duodenal biopsies will be incubated in the presence or not of cytokines and exposed or not to hypoxia. Indeed, 4 groups will be constituted: a control group (no stimulus), a group exposed to hypoxic conditions, a group exposed to inflammatory conditions (cytokines) and a group exposed to both hypoxic an inflammatory conditions.
As primary endpoint, for each group, the OTC activity and the citrulline production in the culture medium will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| only one arm | Other | Procedure: duodenal biopsy during gastroduodenal endoscopyPatients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duodenal biopsy during gastroduodenal endoscopyPatients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed. | Procedure or surgery | only one arm |
Primary outcome
OCT activity in biopsy specimens
Time frame: OCT activity in biopsies after incubation
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 17513438Moinard C, Cynober L. Citrulline: a new player in the control of nitrogen homeostasis. J Nutr. 2007 Jun;137(6 Suppl 2):1621S-1625S. doi: 10.1093/jn/137.6.1621S.
- Background: PubMed 7325229Windmueller HG, Spaeth AE. Source and fate of circulating citrulline. Am J Physiol. 1981 Dec;241(6):E473-80. doi: 10.1152/ajpendo.1981.241.6.E473.
- Background: PubMed 25676932Breuillard C, Cynober L, Moinard C. Citrulline and nitrogen homeostasis: an overview. Amino Acids. 2015 Apr;47(4):685-91. doi: 10.1007/s00726-015-1932-2. Epub 2015 Feb 13.
- Background: PubMed 15542514Osowska S, Moinard C, Neveux N, Loi C, Cynober L. Citrulline increases arginine pools and restores nitrogen balance after massive intestinal resection. Gut. 2004 Dec;53(12):1781-6. doi: 10.1136/gut.2004.042317.
- Background: PubMed 16608884Osowska S, Duchemann T, Walrand S, Paillard A, Boirie Y, Cynober L, Moinard C. Citrulline modulates muscle protein metabolism in old malnourished rats. Am J Physiol Endocrinol Metab. 2006 Sep;291(3):E582-6. doi: 10.1152/ajpendo.00398.2005. Epub 2006 Apr 11.
- Background: PubMed 21344178Faure C, Raynaud-Simon A, Ferry A, Dauge V, Cynober L, Aussel C, Moinard C. Leucine and citrulline modulate muscle function in malnourished aged rats. Amino Acids. 2012 Apr;42(4):1425-33. doi: 10.1007/s00726-011-0841-2. Epub 2011 Feb 23.
- Background: PubMed 23592530Faure C, Morio B, Chafey P, Le Plenier S, Noirez P, Randrianarison-Huetz V, Cynober L, Aussel C, Moinard C. Citrulline enhances myofibrillar constituents expression of skeletal muscle and induces a switch in muscle energy metabolism in malnourished aged rats. Proteomics. 2013 Jul;13(14):2191-201. doi: 10.1002/pmic.201200262. Epub 2013 Jun 10.
- Background: PubMed 23913268Ventura G, Noirez P, Breuille D, Godin JP, Pinaud S, Cleroux M, Choisy C, Le Plenier S, Bastic V, Neveux N, Cynober L, Moinard C. Effect of citrulline on muscle functions during moderate dietary restriction in healthy adult rats. Amino Acids. 2013 Nov;45(5):1123-31. doi: 10.1007/s00726-013-1564-3. Epub 2013 Aug 3.
- BackgroundThe economic burden of lung disease. European white lung book 2013:16-27.
- BackgroundAntonione R. Nutrition in cardiac and pulmonary disease. In Basic in clinical nutrition. Sobotka L. ed. Galen, 4th ed. 485-493.
- BackgroundJonker R. and al. Whole body de novo ARG production and NO synthesis are reduced in COPD patients. Clin.Nutr. 2013;32(S1):S5-S6.
- Background: PubMed 11161457Coeffier M, Miralles-Barrachina O, Le Pessot F, Lalaude O, Daveau M, Lavoinne A, Lerebours E, Dechelotte P. Influence of glutamine on cytokine production by human gut in vitro. Cytokine. 2001 Feb 7;13(3):148-54. doi: 10.1006/cyto.2000.0813.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric FONTAINE, Professor contact
Eric Fontaine, Professor principal investigator
Division of clinical Nutrition-Grenoble University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duodenal biopsy during gastroduodenal endoscopy in people with Hypoxia and Inflammation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric FONTAINE, Professor (efontaine@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT activity in biopsy specimens (time frame: OCT activity in biopsies after incubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820064, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.