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High Dose Insulin Therapy to Improve Liver Function

This study is currently recruiting participants.
Verified August 2011 by McGill University Health Center
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01271140
First received: January 5, 2011
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

Insulin resistance is one of the key factors in defining a progressive course of chronic Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin resistance as an adjuvant way to manage hepatitis C liver disease with promising results.

Long term therapy using high dose insulin was shown to significantly reduce insulin resistance in obese patients. In cardiac and critically ill patients, long term insulin was shown to produce better outcomes mainly by reducing the overt inflammatory response. Furthermore, initial results of ongoing trials are revealing more benefits of insulin therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients undergoing major liver resection was able to maximize their liver function post-operatively. This trial also demonstrated inhibition of the inflammatory response, improvement in liver glycogen, inhibition of apoptosis and stimulation of liver regeneration.

Putting in mind the potential ability of the liver to regenerate and regain better function. The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin resistance over time has led us to see the potential benefits of using insulin therapy on patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the pathophysiology of the disease at a cellular and a molecular level.

The investigators theorize that long-term high insulin therapy would be able to promote better liver function and slow down fibrosis and injury in this population of patients.


Condition Intervention
Hepatitis C Virus
 Drug: Insulin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Liver status improvments (biochemical and histological) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Inflammatory mediators [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin/dextrose clamp Drug: Insulin
Intravenous insulin clamp at a rate of 2 mlu/kg/hr. In adition a titrating dose of 20% dextrose aiming to a blood glucose level of 4 - 5.5 mmol/l.
Other Name: Hyperinsulinemic normoglycemic clamp

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatitis C positive adult patients (serum HCV antibody positive)
  • MELD score 6-15 at the time of inclusion
  • Viral genotype "non-3"
  • Not on antiviral therapy

Exclusion Criteria:

  • HBV or HIV co-infection
  • Evidence of hepatocellular carcinoma at the start of the trial either by imaging and or AFP levels above 400
  • Undetectable HCV viral load (using HCV PCR test)
  • Recent infection or bleeding (in the last 3 months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271140

Locations
Canada, Quebec
McGill University Helath Centre - (Royal Victoria Hospital) Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Mohammed F Shaheen, MD     5142986446     mohammed.shaheen2@mail.mcgill.ca    
Principal Investigator: Peter Metrakos, MD            
Sub-Investigator: Mohammed F Shaheen, MD            
Sub-Investigator: Mazen Hassanain, MD            
Sub-Investigator: Peter Ghali, MD            
Sub-Investigator: Phil Wong, MD            
Sub-Investigator: Thomas Schricker, MD            
Sub-Investigator: Ralph Lattermann, MD            
Sub-Investigator: Tatiana Cabrera, MD            
Sub-Investigator: David Valenti, MD            
Sub-Investigator: Ayat Salman            
Sub-Investigator: Omar Quraishi            
Sub-Investigator: Linda Wykes            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Peter Metrakos, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Peter Metrakos, McGill Unciversity Health Centre
ClinicalTrials.gov Identifier: NCT01271140     History of Changes
Other Study ID Numbers: 10-086-BMA
Study First Received: January 5, 2011
Last Updated: August 2, 2011
Health Authority: Canada : Mcgill University Health Centre

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013