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

Not Applicable

• Conditions: Hypertriglyceridemia
• Interventions: Other: blood sample

• Registration Number: NCT04097990
• Lead Sponsor: Sheba Medical Center

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

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2019-10-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypertriglyceridemia and at least one case of	blood sample	-
hypertriglyceridemia without prior pancreatit	blood sample	-
healthy participants	blood sample	healthy participants

Primary Outcome Measures

Name	Time	Method
Finding a unique pattern in the triglyceride composition	one year	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.

Trial Locations

Locations (1)

Lipid center; 🇮🇱 Tel HaShomer, Israel