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

NCT04097990 | Unknown

• 1 other identifier: 6390-19-SMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

healthy participants

OTHER

healthy participants

Other: blood sample

hypertriglyceridemia without prior pancreatit

OTHER

Other: blood sample

hypertriglyceridemia and at least one case of

OTHER

Other: blood sample

Interventions

blood sample OTHER

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

healthy participants; hypertriglyceridemia and at least one case of; hypertriglyceridemia without prior pancreatit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Healthy participants - triglyceride levels\< 150 mg / dl over the past 5 years, with no diabetes or cardiovascular disease in the background.
• \) Participants with triglyceride levels 1000-5000 mg / dl without acute pancreatitis cases in the past.
• \) Participants with triglyceride levels 1000-5000 mg / dL and at least one case of acute pancreatitis in the last 5 years.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Lipid center

Tel Litwinsky, 5265601, Israel

RECRUITING

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

tamar luvish, BSN

CONTACT

972-35303492; tamar.luvish@sheba.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 20, 2019
• Study Start: October 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)