Acute PancreatitisPhase 4HAPinsulinNCT03501680
Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
A Phase 4 study testing Insulin and plasmapheresis in people with Acute Pancreatitis and Hypertriglyceridemia, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis, Hypertriglyceridemia
- What is being tested?
- Insulin and plasmapheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2018to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG> 500 mg/dL(5.65 mmol/L)
- Onset of abdominal pain within <=48h before admission
- moderate severe or severe Acute Pancreatitis according to Atlanta criteria
- except for other AP causes, such as cholelithiasis, alcohol, drugs and so on
Who cannot join
- other etiologies other than hyperlipidemia leading to AP
- at the same time combined with other etiologies of AP
- appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours
- disseminated intravascular coagulation, or patients with severe active bleeding
- without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.
Read the detailed description
Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.
Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
- Conditions
- Acute Pancreatitis, Hypertriglyceridemia
- Being tested
- Insulin, plasmapheresis
- Keywords
- hyperlipidaemic pancreatitis, Plasmapheresis, insulin
- Medical subject headings
- Pancreatitis, Hypertriglyceridemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
Insulin was injected by insulin pump.
plasmapheresisDevice
Triglyceridemia should be less than 5.65 mmol/l.
| Study group | Role | What they receive |
|---|---|---|
| Group A: intensive insulin | Experimental | Group A: intensive insulin (glycemic control 4.4-6.1mmol/L) Receives: Drug: Insulin |
| Group B: standard insulin | Active comparator | Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), Receives: Drug: Insulin |
| Group C: plasmapheresis | Active comparator | Group C: plasmapheresis Receives: Device: plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of mortality
Number of participants with fatal outcome during hospitalisation
Measured: From admition to hospital discharge, an average of 2 months
Reduction of organ failure
reanl failure, respiratory failure, circulatory failure etal
Measured: From admition to hospital discharge, an average of 2 months
triglyceride levels
triglyceride levels
Measured: From admition to hospital discharge, an average of 2 months
Secondary outcomes (5)
cytokines in serum, urine
IL-6, IL-8, IL-10
Measured: From admition to 7 days
insulin dose
insulin dose
Measured: From admition to 7 days
Severity Score in CT scan
CT Balthazar score/grade or MCTSI score
Measured: From admition to 7 days
TNF-α in serum, urine
TNF-α
Measured: From admition to 7 days
Clinical Severity Score
BISAP score
Measured: From admition to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start6 Jun 2018 (estimated)
- Primary completion8 Mar 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Tao Zhou, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Meng-Tao Zhou, M.D., Study director, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501680
- Sponsor's protocol ID
- HAPinsulin
- Acronym
- HAPinsulin
- Status last verified
- Jun 2018
- First submitted
- 29 Mar 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Lutfi R, Huang J, Wong HR. Plasmapheresis to treat hypertriglyceridemia in a child with diabetic ketoacidosis and pancreatitis. Pediatrics. 2012 Jan;129(1):e195-8. doi: 10.1542/peds.2011-0217. Epub 2011 Dec 26.
PubMed 22201145Tsuang W, Navaneethan U, Ruiz L, Palascak JB, Gelrud A. Hypertriglyceridemic pancreatitis: presentation and management. Am J Gastroenterol. 2009 Apr;104(4):984-91. doi: 10.1038/ajg.2009.27. Epub 2009 Mar 17.
PubMed 19293788
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
- ClinicalTrials.gov ID
- NCT03501680
- Acronym / sponsor ID
- HAPinsulin / HAPinsulin
- Conditions
- Acute Pancreatitis, Hypertriglyceridemia
- Keywords
- hyperlipidaemic pancreatitis, Plasmapheresis, insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (estimated)
- Primary completion
- 8 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Apr 2018 (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.
The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.
Detailed description
Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.
Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: intensive insulin | Experimental | Drug: InsulinGroup A: intensive insulin (glycemic control 4.4-6.1mmol/L) |
| Group B: standard insulin | Active comparator | Drug: InsulinGroup B: standard insulin (glycemic control 7.8-10.0 mmol/L), |
| Group C: plasmapheresis | Active comparator | Device: plasmapheresisGroup C: plasmapheresis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG> 500 mg/dL(5.65 mmol/L)
- Onset of abdominal pain within <=48h before admission
- moderate severe or severe Acute Pancreatitis according to Atlanta criteria
- except for other AP causes, such as cholelithiasis, alcohol, drugs and so on
Key exclusion criteria (5 listed)
- other etiologies other than hyperlipidemia leading to AP
- at the same time combined with other etiologies of AP
- appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours
- disseminated intravascular coagulation, or patients with severe active bleeding
- without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
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 |
|---|---|---|
| InsulinGroup A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis. Insulin was injected by insulin pump. | Drug | Group A: intensive insulin, Group B: standard insulin |
| plasmapheresisTriglyceridemia should be less than 5.65 mmol/l. | Device | Group C: plasmapheresis |
Primary outcome
Reduction of mortality
Time frame: From admition to hospital discharge, an average of 2 months
Number of participants with fatal outcome during hospitalisation
Reduction of organ failure
Time frame: From admition to hospital discharge, an average of 2 months
reanl failure, respiratory failure, circulatory failure etal
triglyceride levels
Time frame: From admition to hospital discharge, an average of 2 months
triglyceride levels
5 secondary outcomes
cytokines in serum, urine
Time frame: From admition to 7 days
insulin dose
Time frame: From admition to 7 days
Severity Score in CT scan
Time frame: From admition to 7 days
TNF-α in serum, urine
Time frame: From admition to 7 days
Clinical Severity Score
Time frame: From admition to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 22201145Lutfi R, Huang J, Wong HR. Plasmapheresis to treat hypertriglyceridemia in a child with diabetic ketoacidosis and pancreatitis. Pediatrics. 2012 Jan;129(1):e195-8. doi: 10.1542/peds.2011-0217. Epub 2011 Dec 26.
- Background: PubMed 19293788Tsuang W, Navaneethan U, Ruiz L, Palascak JB, Gelrud A. Hypertriglyceridemic pancreatitis: presentation and management. Am J Gastroenterol. 2009 Apr;104(4):984-91. doi: 10.1038/ajg.2009.27. Epub 2009 Mar 17.
- Individual participant dataSharing planned: Undecided
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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.
Meng-Tao Zhou, M.D. study director
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin and plasmapheresis in people with Acute Pancreatitis and Hypertriglyceridemia, run by First Affiliated Hospital of Wenzhou Medical University.
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 4 inclusion and 5 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 6 Jun 2018. 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. 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 KeQing Shi, M.D. ((086)15858515296, skochilly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of mortality (time frame: From admition to hospital discharge, an average of 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501680, which also lists 2 linked publications.
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 6 Jun 2018.