Metabolic SyndromeOBELIXNCT04226014
Observational Cohort of Pancreatic Echo-endoscopy
An observational study of Metabolic Syndrome and Obesity, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites in France.
Trial summary
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Obesity, Hepatic Steatosis
- What is being tested?
- Endoscopic ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Jul 2018to 15 Sep 2019
- Phase
- Observational
- 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
Study population: Any patient receiving a high echo-endography meeting the inclusion criteria will be included.
Who may be able to join
- any consecutive patient, having a high echo-endoscopy
- for an extra pancreatic cause, such as the search for a cholelithiasis, (the pancreas will be studied completely)
- for esophageal pathologies, (the pancreas will be studied completely)
- for gastric pathologies, (the pancreas will be studied completely)
- for cystic lesions of the pancreas (pancreas studied upstream and downstream)
- for submucosal tumors (esophageal / gastric / duodenal)
- for abdominal pain of undetermined origin
Who cannot join
- Patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis.
- Patients having contraindication to general anesthesia
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Polyclinique du Beaujolais
Arnas, 69400
Clinique du Val d'Ouest
Écully, 69130
Hôpital privé Jean Mermoz
Lyon, 69008
Clinique du Trocadéro
Paris, 75116
Clinique des Portes du Sud
Vénissieux, 69694
About this study
Official title: Score of Echogenicity and Pancreatic Echo-endoscopy
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.
The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?
Read the detailed description
Little is known about the pathogenesis of the fatty pancreas. Fat can replace acinar cells and / or pancreatic endocrine cells (1). To date, there are no biomarkers allowing the detection of a fatty pancreas. It appears that older age, male, obesity, alcohol consumption, high triglycerides, high ALT, diabetes or insulin resistance, fatty liver and metabolic syndrome are risk factors for a fatty pancreas (2,3,4).To the investigator's knowledge, these different factors have not been evaluated on the impact of pancreatic echogenecity in endosonography. The objective of this study is to correlate the factors making up the metabolic syndrome with pancreatic echogenecity.
- Conditions
- Metabolic Syndrome, Obesity, Hepatic Steatosis
- Being tested
- Endoscopic ultrasound
- Keywords
- pancreatic echogenecity, Hepatic Steatosis, Metabolic Syndrome, Obesity
- Medical subject headings
- Metabolic Syndrome, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundProcedure or surgery
Echo-endoscopy ultrasound is an examination that presents little risk. However, any medical act, exploration, intervention even conducted under conditions of competence and safety in accordance with current data of medicine and the regulations in force, conceals a risk of complications. In particular, esophageal perforations can occur. They are often favored by underlying lesions (tumor, diverticulum, anatomical variants ...). Other complications are possible such as cardiovascular, respiratory or infectious disorders, as with any anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Patients with echo-endoscopic ultrasound of the pancreas | Patients requiring endoscopic ultrasound of the pancreas were included in the cohort. Receives: Procedure: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome
Three categories of echogenicity have been defined. The presence of one or more factors of the metabolic syndrome was correlated with the category of pancreatic echogenicity defined by the experts
Measured: During the reading of the echo-endoscopic procedure
Secondary outcomes (1)
Comparaison of the echogenicity of the pancreas with respect to the liver and to the spleen will be made.
The pancreatic echogenicity score will be assessed with the following criteria
- The visibility of Wirsung in three categories: excellent, average, poor
- that of the contours in 3 categories good or average or poor visualization of the splenic vein
- that of the parenchyma in 3 categories: normal, brilliant, not too obstructing the visualization of the Wirsung and the splenic vein, very promising embarrassing the visualization of the Wirsung and the splenic vein
- with in addition a -heterogeneous or - homogeneous item for the parenchyma.
Measured: During the reading of the echo-endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start17 Jul 2018
- Primary completion16 Apr 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique du Val d'ouest
- Responsible party
- Sponsor
- Investigators
- Anne-Marie MARION-AUDIBERT, MD, PhD, Principal investigator, Clinique du Val d'ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226014
- Sponsor's protocol ID
- OBELIX
- Acronym
- OBELIX
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Score of Echogenicity and Pancreatic Echo-endoscopy
- ClinicalTrials.gov ID
- NCT04226014
- Acronym / sponsor ID
- OBELIX / OBELIX
- Conditions
- Metabolic Syndrome, Obesity, Hepatic Steatosis
- Keywords
- pancreatic echogenecity, Hepatic Steatosis, Metabolic Syndrome, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Collaborators
- Clinique du Val d'ouest
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 13 Jan 2020 (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.
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.
The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?
Detailed description
Little is known about the pathogenesis of the fatty pancreas. Fat can replace acinar cells and / or pancreatic endocrine cells (1). To date, there are no biomarkers allowing the detection of a fatty pancreas. It appears that older age, male, obesity, alcohol consumption, high triglycerides, high ALT, diabetes or insulin resistance, fatty liver and metabolic syndrome are risk factors for a fatty pancreas (2,3,4).To the investigator's knowledge, these different factors have not been evaluated on the impact of pancreatic echogenecity in endosonography. The objective of this study is to correlate the factors making up the metabolic syndrome with pancreatic echogenecity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with echo-endoscopic ultrasound of the pancreas | – | Procedure: Endoscopic ultrasoundPatients requiring endoscopic ultrasound of the pancreas were included in the cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient receiving a high echo-endography meeting the inclusion criteria will be included.
Key inclusion criteria (7 listed)
- any consecutive patient, having a high echo-endoscopy
- for an extra pancreatic cause, such as the search for a cholelithiasis, (the pancreas will be studied completely)
- for esophageal pathologies, (the pancreas will be studied completely)
- for gastric pathologies, (the pancreas will be studied completely)
- for cystic lesions of the pancreas (pancreas studied upstream and downstream)
Key exclusion criteria (2 listed)
- Patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis.
- Patients having contraindication to general anesthesia
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 |
|---|---|---|
| Endoscopic ultrasoundEcho-endoscopy ultrasound is an examination that presents little risk. However, any medical act, exploration, intervention even conducted under conditions of competence and safety in accordance with current data of medicine and the regulations in force, conceals a risk of complications. In particular, esophageal perforations can occur. They are often favored by underlying lesions (tumor, diverticulum, anatomical variants ...). Other complications are possible such as cardiovascular, respiratory or infectious disorders, as with any anesthesia. | Procedure or surgery | Patients with echo-endoscopic ultrasound of the pancreas |
Primary outcome
Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome
Time frame: During the reading of the echo-endoscopic procedure
Three categories of echogenicity have been defined. The presence of one or more factors of the metabolic syndrome was correlated with the category of pancreatic echogenicity defined by the experts
1 secondary outcome
Comparaison of the echogenicity of the pancreas with respect to the liver and to the spleen will be made.
Time frame: During the reading of the echo-endoscopic procedure
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 13 Jan 2020.
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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.
Anne-Marie MARION-AUDIBERT, MD, PhD principal investigator
Clinique du Val d'ouest
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Obesity, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 5 sites 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 7 inclusion and 2 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Correlation of the pancreatic echogenicity by endoscopic ultrasound with the metabolic syndrome (time frame: During the reading of the echo-endoscopic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.