Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Hypertriglyceridemia Clinical Trial

— HAPinsulin  

Official title:

Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03501680
• Other study ID #: HAPinsulin
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 6, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2018
• Source: First Affiliated Hospital of Wenzhou Medical Univeristy
• Contact: KeQing Shi, M.D.
• Phone: (086)15858515296
• Email: skochilly[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: March 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Hypertriglyceridemia
• Pancreatitis

Intervention

Drug:
• Insulin
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.

Device:
• plasmapheresis
Triglyceridemia should be less than 5.65 mmol/l.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical Univeristy

References & Publications (2)

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. — View Citation

Tsuang 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genomics	cfDNA et.al.	From admition to 7 days
Other	Clinical Severity Score	Ranson score	From admition to 7 days
Other	Clinical Severity Score	Apache2	From admition to 7 days
Primary	Reduction of mortality	Number of participants with fatal outcome during hospitalisation	From admition to hospital discharge, an average of 2 months
Primary	Reduction of organ failure	reanl failure, respiratory failure, circulatory failure etal	From admition to hospital discharge, an average of 2 months
Primary	triglyceride levels	triglyceride levels	From admition to hospital discharge, an average of 2 months
Secondary	cytokines in serum, urine	IL-6, IL-8, IL-10	From admition to 7 days
Secondary	insulin dose	insulin dose	From admition to 7 days
Secondary	Severity Score in CT scan	CT Balthazar score/grade or MCTSI score	From admition to 7 days
Secondary	TNF-a in serum, urine	TNF-a	From admition to 7 days
Secondary	Clinical Severity Score	BISAP score	From admition to 7 days