Insulin and Standard Management in Hypertriglyceridemic A... | NCT05487833

Studies
Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

NCT05487833

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

Nov 1, 2022Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Hypertriglyceridemia
Acute Pancreatitis

Interventions

insulin
standard treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Apr 6, 2022

First Submission Date that Met QC Criteria

Aug 3, 2022

First Posted Date

Aug 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jakob Gubensek, Principal investigator, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insulin	Experimental		Biological: insulin
standard management	Placebo Comparator		Other: standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin	Biological	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute pancreatitis
triglycerides > 15 mmol/l

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samo Plut, MD	Contact	00386 1 522 4165		samo.plut@kclj.si

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia
D010195	Pancreatitis

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided