Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

October 31, 2022 updated by: Jakob Gubensek, University Medical Centre Ljubljana

Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute pancreatitis
  • triglycerides > 15 mmol/l

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: insulin
Biological: insulin
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
PLACEBO_COMPARATOR: standard management
Other: standard treatment
infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%triglyceride reduction
Time Frame: after 18 hours of treatment
change in triglycerides, expressed as % of initial value
after 18 hours of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of hypoglycemia
Time Frame: during treatment with insulin, up to day 5
during treatment with insulin, up to day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

September 1, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (ACTUAL)

August 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InzulinHTGAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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