High Dose Insulin Therapy to Improve Liver Function

NCT01271140 | Unknown DMC

• 1 other identifier: 10-086-BMA
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Liver status improvments (biochemical and histological)

  6 months

Secondary Outcomes (2)

• Insulin resistance

  6 months

• Inflammatory mediators

  6 months

Study Arms (1)

Insulin/dextrose clamp

EXPERIMENTAL

Drug: Insulin

Interventions

Insulin DRUG

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.

Also known as: Hyperinsulinemic normoglycemic clamp

Insulin/dextrose clamp

Eligibility Criteria

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

You may qualify if:

• Hepatitis C positive adult patients (serum HCV antibody positive)
• Viral genotype "non-3"
• Not on antiviral therapy

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Helath Centre - (Royal Victoria Hospital)

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Insulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Metrakos, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Multiorgan Transplant Program-MUHC

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

CA (1)