Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05487833

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia Acute Pancreatitis	Biological: insulin Other: standard treatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

%triglyceride reduction [after 18 hours of treatment]
change in triglycerides, expressed as % of initial value

Secondary Outcome Measures

incidence of hypoglycemia [during treatment with insulin, up to day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

acute pancreatitis
triglycerides > 15 mmol/l

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jakob Gubensek, Principal investigator, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT05487833

Other Study ID Numbers:

InzulinHTGAP

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatitis

Hypertriglyceridemia

Insulin

Study Results

No Results Posted as of Aug 4, 2022