HypertriglyceridemiaPhase 4NCT05487833
Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis
A Phase 4 study testing insulin and standard treatment in people with Hypertriglyceridemia and Acute Pancreatitis, run by University Medical Centre Ljubljana.
Trial summary
To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia, Acute Pancreatitis
- What is being tested?
- insulin and standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute pancreatitis
- triglycerides > 15 mmol/l
Who cannot join
- diabetes on peroral therapy or insulin
- blood glucose > 11 mmol/l
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Hypertriglyceridemia, Acute Pancreatitis
- Being tested
- insulin, standard treatment
- Medical subject headings
- Hypertriglyceridemia, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulinBiological
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
standard treatmentOther
infusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours
| Study group | Role | What they receive |
|---|---|---|
| insulin | Experimental | Not described Receives: Biological: insulin |
| standard management | Placebo comparator | Not described Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
%triglyceride reduction
change in triglycerides, expressed as % of initial value
Measured: after 18 hours of treatment
Secondary outcomes (1)
incidence of hypoglycemia
Measured: during treatment with insulin, up to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Gubensek, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487833
- Sponsor's protocol ID
- InzulinHTGAP
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes
- ClinicalTrials.gov ID
- NCT05487833
- Acronym / sponsor ID
- InzulinHTGAP
- Conditions
- Hypertriglyceridemia, Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin | Experimental | Biological: insulin |
| standard management | Placebo comparator | Other: standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute pancreatitis
- triglycerides > 15 mmol/l
Key exclusion criteria (3 listed)
- diabetes on peroral therapy or insulin
- blood glucose > 11 mmol/l
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin5% 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 | Biological | insulin |
| standard treatmentinfusion of a balanced solution, infused at a rate determined by the treating physician, treatment duration: 18 hours | Other | standard management |
Primary outcome
%triglyceride reduction
Time frame: after 18 hours of treatment
change in triglycerides, expressed as % of initial value
1 secondary outcome
incidence of hypoglycemia
Time frame: during treatment with insulin, up to day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes. deidentified IPD that underlie results in a publication will be available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin and standard treatment in people with Hypertriglyceridemia and Acute Pancreatitis, run by University Medical Centre Ljubljana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samo Plut, MD (00386 1 522 4165, samo.plut@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%triglyceride reduction (time frame: after 18 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.