Study of Circulating Levels of Glicentin (GLICENTINEDIGE)

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.

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 Overview

• Status: Completed
• Conditions: Ischemia Bowel
• Intervention / Treatment: Other: additional blood tube; Other: additional blood sample

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • University Nice Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: bowel ischemia	Other: additional blood tube; sampling of an additional tube at the usual blood test to determine the glicentin level
Other: non-digestive abdominal pain	Other: additional blood tube; sampling of an additional tube at the usual blood test to determine the glicentin level; Other: additional blood sample; for le group control, another blood sample is taken outside the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference of at least 20% of the serum glicentin dosage in the "intestinal ischemia" group versus the "control" volunteers.	glicentine dosage	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 18-AOI-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No