Study of Circulating Levels of Glicentin (GLICENTINEDIGE)
Primary Purpose
Ischemia Bowel
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood tube
additional blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Ischemia Bowel
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Nice Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
bowel ischemia
non-digestive abdominal pain
Arm Description
Outcomes
Primary Outcome Measures
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers.
glicentine dosage
Secondary Outcome Measures
Full Information
NCT ID
NCT03671928
First Posted
September 13, 2018
Last Updated
September 14, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03671928
Brief Title
Study of Circulating Levels of Glicentin
Acronym
GLICENTINEDIGE
Official Title
Study of Circulating Glicentin Levels in Patients With Intestinal Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Bowel
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bowel ischemia
Arm Type
Other
Arm Title
non-digestive abdominal pain
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
additional blood tube
Intervention Description
sampling of an additional tube at the usual blood test to determine the glicentin level
Intervention Type
Other
Intervention Name(s)
additional blood sample
Intervention Description
for le group control, another blood sample is taken outside the usual care.
Primary Outcome Measure Information:
Title
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers.
Description
glicentine dosage
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien MASSALOU
Phone
33492038614
Email
massalou.d@chu-nice.fr
Facility Information:
Facility Name
University Nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien MASSALOU
Phone
33492038614
Email
massalou.d@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Damien MASSALOU
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Circulating Levels of Glicentin
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