Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Primary Purpose
Hypertriglyceridemia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertriglyceridemia
Eligibility Criteria
Inclusion Criteria:
1) Healthy participants - triglyceride levels< 150 mg / dl over the past 5 years, with no diabetes or cardiovascular disease in the background.
2) Participants with triglyceride levels 1000-5000 mg / dl without acute pancreatitis cases in the past.
3) Participants with triglyceride levels 1000-5000 mg / dL and at least one case of acute pancreatitis in the last 5 years.
Exclusion Criteria:
- A past pancreatitis event that occurred with measurement of triglyceride levels greater than 5000 mg / dL.
- Acute pancreatitis events in the past that occurred for a cause other than hypertriglyceridemia -
Sites / Locations
- Lipid centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
healthy participants
hypertriglyceridemia without prior pancreatit
hypertriglyceridemia and at least one case of
Arm Description
healthy participants
Outcomes
Primary Outcome Measures
Finding a unique pattern in the triglyceride composition
Fatty acids will be analyzed in a gas-chromatographer and their concentration in plasma will be measured by comparison to a known-consentration standard fatty acid solution. Concentration will be presented as mg/dL (miligrams per deciliter) or as a fold change concentration relative to the concentration in plasma of control subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04097990
Brief Title
Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Official Title
Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
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
) Finding a unique pattern in the triglyceride composition of patients with hypertriglyceridemia that increases the chances of getting pancreatitis and which can serve as a laboratory predictive tool for patients and define them as a at-risk population.
2) Finding the typical fatty acid composition in triglycerides for patients at high risk of pancreatic acute inflammation that can be used to develop unique drugs for pancreatic acute inflammation caused by high levels of triglycerides.
Detailed Description
The study will be conducted at the Sheba Medical Center Lipid Institute, number of participants: 10 healthy participants, 10 participants with hypertriglyceridemia without prior pancreatitis and 10 participants with hypertriglyceridemia and at least one case of severe pancreatitis in the last 5 years.
A total of 30 participants Participants who are found suitable during their visit to the Lipid Institute Clinic or during their hospitalization at Sheba Medical Center will receive an explanation of the study, will be asked to sign a consent form. And check the fatty acid levels. Healthy volunteers who meet the inclusion conditions will also be asked to sign a consent form and their blood will be taken and kept frozen for further study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 healthy participants, 10 participants with hypertriglyceridemia without prior pancreatitis and 10 participants with hypertriglyceridemia and at least one case of severe pancreatitis in the last 5 years.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
healthy participants
Arm Type
Other
Arm Description
healthy participants
Arm Title
hypertriglyceridemia without prior pancreatit
Arm Type
Other
Arm Title
hypertriglyceridemia and at least one case of
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
a 5 cc blood sample will be taken after a 12-hour fast for separation of triglycerides from the serum and for checking fatty acid levels
Primary Outcome Measure Information:
Title
Finding a unique pattern in the triglyceride composition
Description
Fatty acids will be analyzed in a gas-chromatographer and their concentration in plasma will be measured by comparison to a known-consentration standard fatty acid solution. Concentration will be presented as mg/dL (miligrams per deciliter) or as a fold change concentration relative to the concentration in plasma of control subjects.
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Healthy participants - triglyceride levels< 150 mg / dl over the past 5 years, with no diabetes or cardiovascular disease in the background.
2) Participants with triglyceride levels 1000-5000 mg / dl without acute pancreatitis cases in the past.
3) Participants with triglyceride levels 1000-5000 mg / dL and at least one case of acute pancreatitis in the last 5 years.
Exclusion Criteria:
A past pancreatitis event that occurred with measurement of triglyceride levels greater than 5000 mg / dL.
Acute pancreatitis events in the past that occurred for a cause other than hypertriglyceridemia -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tamar luvish, BSN
Phone
972-35303492
Email
tamar.luvish@sheba.gov.il
Facility Information:
Facility Name
Lipid center
City
Tel HaShomer
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tamar luvish, BSN
Phone
972-35303492
Email
tamar.luvish@sheba.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Absolute medical confidentiality will be kept on all participants' details. All details will be kept locked while the tests containing the participants' blood or the biological materials produced from it will be marked in serial numbers only.
Learn more about this trial
Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
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