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

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ClinicalTrials.gov Identifier: NCT04097990
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Rom Keshet, 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.


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Other: blood sample Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
healthy participants
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

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

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




Primary Outcome Measures :
  1. Finding a unique pattern in the triglyceride composition [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097990


Contacts
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Contact: tamar luvish, BSN 972-35303492 tamar.luvish@sheba.gov.il

Locations
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Israel
Lipid center Recruiting
Tel HaShomer, Israel, 5265601
Contact: tamar luvish, BSN    972-35303492    tamar.luvish@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Dr. Rom Keshet, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04097990     History of Changes
Other Study ID Numbers: 6390-19-SMC
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Hypertriglyceridemia
Pancreatic Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases