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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04097990
• Other study ID #: 6390-19-SMC
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: July 2020
• Source: Sheba Medical Center
• Contact: tamar luvish, BSN
• Phone: 972-35303492
• Email: tamar.luvish[@]sheba.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
Israel	Lipid center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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