Ischemia BowelGLICENTINEDIGENCT03671928
Study of Circulating Levels of Glicentin
A study testing additional blood tube and additional blood sample in people with Ischemia Bowel, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Hormones derived from proglucagon represent a family of peptides produced by the alpha cells of the pancreas and by the intestinal L cells. In the pancreas, the maturation of proglucagon mainly leads to the synthesis of glucagon, while in the intestine, the cleavage of proglucagon allows the synthesis of different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Bowel
- What is being tested?
- additional blood tube and additional blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 1 Mar 2023
- 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
- For patients with intestinal ischemia
- The combination of abdominal pain, altered general condition with abdominal defence and venous or arterial hyperlactatemia will be signs suggestive of a diagnosis of digestive ischemia.
- Patients suspected of digestive ischemia with the following comorbidities may be included as clinical suspicion and excluded post-operatively: emboligenic heart disease, arteriopathy, aortic and/or digestive atheromatosis.
- Patients with suspected digestive ischemia and functional scanning ileus.
- Patients with intestinal ischemia proven by CT scan with contrast injection: arterial abnormality such as dissection of an artery for digestive use, thrombosis or embolism of an artery for digestive use; intestinal or colonic thickening suggestive of reversible ischemic suffering of the digestive tract; parietal pneumatosis; gastrointestinal parietal enhancement abnormality (hypo-density ranges or total absence of enhancement).
- The following pathologies will be taken into account: mesenteric ischemia by embolism or thrombosis.
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- Age over 18 years old
- Able to understand the study
- Affiliation to a social security system
- Signing of an informed consent
- Accept participation in the study (collection of a Non-Opposition)
- For the control group
- Age over 18 years old
- Able to understand the study
- Affiliation to a social security system
- Signing of an informed consent
- No personal history of colorectal cancer and obesity
- Admission to the Emergency Department of the University Hospital of Nice for abdominal pain with EVA > 3/10 of non-intestinal origin: nephritic colic, hepatobiliary pathology, gynaecological disease, etc.
- Abdominal CT excluding digestive tract pathology
- Accept participation in the study
Who cannot join
- History of bariatric or digestive surgery (stomach, small intestine, colon or rectum)
- History of chronic inflammatory bowel disease
- Obese patients (BMI> 30kg/m2)
- History of type 1 diabetes or insulin treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Circulating Glicentin Levels in Patients With Intestinal Ischemia
Hormones derived from proglucagon represent a family of peptides produced by the alpha cells of the pancreas and by the intestinal L cells. In the pancreas, the maturation of proglucagon mainly leads to the synthesis of glucagon, while in the intestine, the cleavage of proglucagon allows the synthesis of different peptides including glicentine, oxyntomodulin, Glucagon Like Peptide-1 (GLP-1) and Glucagon Like Peptide-2 (GLP-2).
Glicentin is produced by L cells throughout the digestive tract, from the small intestine to the rectum, with a majority secretion in the colon. Studies in humans and animals have shown its role in the intestinal mucosa. It has a stimulating effect on the proliferation of the intestinal mucosa as well as an effect on smooth muscle cells and regulates trophicity and intestinal motility. Its circulating rate could be modified in case of intestinal ischemia. Mesenteric ischemia is a major diagnostic problem with high morbidity and mortality, particularly in the event of delayed treatment.
Read more
The sensitivity and specificity of current markers are low. The identification of new biomarkers of the disease would improve the diagnosis and management of patients with the disease.
The objective of the project is to determine a difference in circulating glicentin levels in patients with intestinal ischemia versus a control group.
On this prospective monocentric study, 40 patients with digestive ischemia will be included in the Emergency Department of the University Hospital of Nice. A control group of 40 patients with abdominal pain will be formed. The circulating glicentin levels will be measured on serum by Elisa technique at the Biochemistry Laboratory of the University Hospital of Nice, work that has been published in 3 scientific journals allowing us to develop and validate the technique.The staff will determine whether patients with digestive ischemia have impaired serum glicentin levels.
The evaluation of the interest of new biological markers of mesenteric ischemia such as glicentine would constitute a definite diagnostic advance. This project could eventually offer new diagnostic and/or therapeutic perspectives in the management of these patients.
- Conditions
- Ischemia Bowel
- Being tested
- additional blood tube, additional blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood tubeOther
sampling of an additional tube at the usual blood test to determine the glicentin level
additional blood sampleOther
for le group control, another blood sample is taken outside the usual care.
| Study group | Role | What they receive |
|---|---|---|
| bowel ischemia | Other | Not described Receives: Other: additional blood tube |
| non-digestive abdominal pain | Other | Not described Receives: Other: additional blood tube; Other: additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers.
glicentine dosage
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start3 Feb 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemia BowelStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671928
- Sponsor's protocol ID
- 18-AOI-12
- Acronym
- GLICENTINEDIGE
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2018
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Hamwi A, Hamard F, Hinault-Boyer C, Raffort J, Lareyre F, Grober J, Massalou D. New Biomarkers of Acute Intestinal Ischemia: A Prospective Study Validating the Interest of Glucagon-Like Peptide-1 and -2. J Am Coll Surg. 2025 Oct 1;241(4):610-618. doi: 10.1097/XCS.0000000000001453. Epub 2025 Sep 16.
PubMed 40392545
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Glicentin Levels in Patients With Intestinal Ischemia
- ClinicalTrials.gov ID
- NCT03671928
- Acronym / sponsor ID
- GLICENTINEDIGE / 18-AOI-12
- Conditions
- Ischemia Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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.
Hormones derived from proglucagon represent a family of peptides produced by the alpha cells of the pancreas and by the intestinal L cells. In the pancreas, the maturation of proglucagon mainly leads to the synthesis of glucagon, while in the intestine, the cleavage of proglucagon allows the synthesis of different peptides including glicentine, oxyntomodulin, Glucagon Like Peptide-1 (GLP-1) and Glucagon Like Peptide-2 (GLP-2).
Glicentin is produced by L cells throughout the digestive tract, from the small intestine to the rectum, with a majority secretion in the colon. Studies in humans and animals have shown its role in the intestinal mucosa. It has a stimulating effect on the proliferation of the intestinal mucosa as well as an effect on smooth muscle cells and regulates trophicity and intestinal motility. Its circulating rate could be modified in case of intestinal ischemia. Mesenteric ischemia is a major diagnostic problem with high morbidity and mortality, particularly in the event of delayed treatment.
The sensitivity and specificity of current markers are low. The identification of new biomarkers of the disease would improve the diagnosis and management of patients with the disease.
The objective of the project is to determine a difference in circulating glicentin levels in patients with intestinal ischemia versus a control group.
On this prospective monocentric study, 40 patients with digestive ischemia will be included in the Emergency Department of the University Hospital of Nice. A control group of 40 patients with abdominal pain will be formed. The circulating glicentin levels will be measured on serum by Elisa technique at the Biochemistry Laboratory of the University Hospital of Nice, work that has been published in 3 scientific journals allowing us to develop and validate the technique.The staff will determine whether patients with digestive ischemia have impaired serum glicentin levels.
The evaluation of the interest of new biological markers of mesenteric ischemia such as glicentine would constitute a definite diagnostic advance. This project could eventually offer new diagnostic and/or therapeutic perspectives in the management of these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bowel ischemia | Other | Other: additional blood tube |
| non-digestive abdominal pain | Other | Other: additional blood tube, Other: additional blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- For patients with intestinal ischemia
- The combination of abdominal pain, altered general condition with abdominal defence and venous or arterial hyperlactatemia will be signs suggestive of a diagnosis of digestive ischemia.
- Patients suspected of digestive ischemia with the following comorbidities may be included as clinical suspicion and excluded post-operatively: emboligenic heart disease, arteriopathy, aortic and/or digestive atheromatosis.
- Patients with suspected digestive ischemia and functional scanning ileus.
- Patients with intestinal ischemia proven by CT scan with contrast injection: arterial abnormality such as dissection of an artery for digestive use, thrombosis or embolism of an artery for digestive use; intestinal or colonic thickening suggestive of reversible ischemic suffering of the digestive tract; parietal pneumatosis; gastrointestinal parietal enhancement abnormality (hypo-density ranges or total absence of enhancement).
Key exclusion criteria (4 listed)
- History of bariatric or digestive surgery (stomach, small intestine, colon or rectum)
- History of chronic inflammatory bowel disease
- Obese patients (BMI> 30kg/m2)
- History of type 1 diabetes or insulin treatment
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 |
|---|---|---|
| additional blood tubesampling of an additional tube at the usual blood test to determine the glicentin level | Other | bowel ischemia, non-digestive abdominal pain |
| additional blood samplefor le group control, another blood sample is taken outside the usual care. | Other | non-digestive abdominal pain |
Primary outcome
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers.
Time frame: 24 months
glicentine dosage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 40392545El Hamwi A, Hamard F, Hinault-Boyer C, Raffort J, Lareyre F, Grober J, Massalou D. New Biomarkers of Acute Intestinal Ischemia: A Prospective Study Validating the Interest of Glucagon-Like Peptide-1 and -2. J Am Coll Surg. 2025 Oct 1;241(4):610-618. doi: 10.1097/XCS.0000000000001453. Epub 2025 Sep 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood tube and additional blood sample in people with Ischemia Bowel, run by Centre Hospitalier Universitaire de Nice 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 20 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: finished, as of the sponsor's last update on 24 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers. (time frame: 24 months). 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 NCT03671928, which also lists 1 linked publication.
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 24 Mar 2026.