NCT03501680

Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-06
• Primary completion: 2020-03-08
• Completion: 2020-12-31
• First posted: 2018-04-18
• Last updated: 2018-06-06

Regulatory

• FDA-regulated drug study
• FDA-regulated device study