Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis

) 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.

Study Overview

• Status: Unknown
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Other: blood sample

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tamar luvish, BSN; Phone Number: 972-35303492; Email: tamar.luvish@sheba.gov.il

Study Locations

• Israel
  • Tel HaShomer, Israel, 5265601
    • Recruiting
    • Lipid center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. A past pancreatitis event that occurred with measurement of triglyceride levels greater than 5000 mg / dL.
2. Acute pancreatitis events in the past that occurred for a cause other than hypertriglyceridemia -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healthy participants	Other: blood sample; 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
Other: hypertriglyceridemia without prior pancreatit	Other: blood sample; 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
Other: hypertriglyceridemia and at least one case of	Other: blood sample; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Pancreatic Diseases; Pancreatitis; Hypertriglyceridemia
• Other Study ID Numbers: 6390-19-SMC

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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