Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

NCT03501680 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: HAPinsulin
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Pancreatitis; Hypertriglyceridemia

Keywords

hyperlipidaemic pancreatitis; Plasmapheresis; insulin

Outcome Measures

Primary Outcomes (3)

• Reduction of mortality

  Number of participants with fatal outcome during hospitalisation

  From admition to hospital discharge, an average of 2 months

• Reduction of organ failure

  reanl failure, respiratory failure, circulatory failure etal

  From admition to hospital discharge, an average of 2 months

• triglyceride levels

  triglyceride levels

  From admition to hospital discharge, an average of 2 months

Secondary Outcomes (5)

• cytokines in serum, urine

  From admition to 7 days

• insulin dose

  From admition to 7 days

• Severity Score in CT scan

  From admition to 7 days

• TNF-α in serum, urine

  From admition to 7 days

• Clinical Severity Score

  From admition to 7 days

Other Outcomes (3)

• Genomics

  From admition to 7 days

• Clinical Severity Score

  From admition to 7 days

• Clinical Severity Score

  From admition to 7 days

Study Arms (3)

Group A: intensive insulin

EXPERIMENTAL

Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)

Drug: Insulin

Group B: standard insulin

ACTIVE COMPARATOR

Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),

Drug: Insulin

Group C: plasmapheresis

ACTIVE COMPARATOR

Group C: plasmapheresis

Device: plasmapheresis

Interventions

Insulin DRUG

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.

Group A: intensive insulin; Group B: standard insulin

plasmapheresis DEVICE

Triglyceridemia should be less than 5.65 mmol/l.

Group C: plasmapheresis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Related 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.

  PMID: 22201145 BACKGROUND

• 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.

  PMID: 19293788 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Hypertriglyceridemia; Insulin Resistance

Interventions

Insulin; Plasmapheresis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Meng-Tao Zhou, M.D.

  The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

  STUDY DIRECTOR

Central Study Contacts

KeQing Shi, M.D.

CONTACT

(086)15858515296; skochilly@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the department of pancreatitis; the president of First Affiliated Hospital of Wenzhou Medical Univeristy

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 18, 2018
• Study Start: June 6, 2018
• Primary Completion: March 8, 2020
• Study Completion: December 31, 2020
• Last Updated: June 6, 2018

Record last verified: 2018-06