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Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

Primary Purpose

Hypertriglyceridemia, Acute Pancreatitis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
insulin
standard treatment
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute pancreatitis
  • triglycerides > 15 mmol/l

Exclusion Criteria:

  • diabetes on peroral therapy or insulin
  • blood glucose > 11 mmol/l
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    insulin

    standard management

    Arm Description

    Outcomes

    Primary Outcome Measures

    %triglyceride reduction
    change in triglycerides, expressed as % of initial value

    Secondary Outcome Measures

    incidence of hypoglycemia

    Full Information

    First Posted
    April 6, 2022
    Last Updated
    October 31, 2022
    Sponsor
    University Medical Centre Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05487833
    Brief Title
    Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis
    Official Title
    Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia, Acute Pancreatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    insulin
    Arm Type
    Experimental
    Arm Title
    standard management
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    insulin
    Intervention Description
    5% glucose in 0.9% NaCl with 4 IU of short acting insulin per 500 ml added, infused at a rate determined by the treating physician, treatment duration: 18 hours
    Intervention Type
    Other
    Intervention Name(s)
    standard treatment
    Intervention Description
    infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours
    Primary Outcome Measure Information:
    Title
    %triglyceride reduction
    Description
    change in triglycerides, expressed as % of initial value
    Time Frame
    after 18 hours of treatment
    Secondary Outcome Measure Information:
    Title
    incidence of hypoglycemia
    Time Frame
    during treatment with insulin, up to day 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute pancreatitis triglycerides > 15 mmol/l Exclusion Criteria: diabetes on peroral therapy or insulin blood glucose > 11 mmol/l pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samo Plut, MD
    Phone
    00386 1 522 4165
    Email
    samo.plut@kclj.si

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request

    Learn more about this trial

    Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

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