Lifestyle Intervention Targetting Obesity and Insulin Resistance in Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Venessa Pattullo, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00755742
First received: September 17, 2008
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

Chronic hepatitis C (CHC) infection affects approximately 1 in 100 Canadians. Untreated, CHC has significant long-term consequences including cirrhosis, liver cancer and liver failure. CHC is intrinsically linked to both obesity and insulin resistance (IR) or "pre-diabetes", their co-existence worsens overall health outcomes. We have demonstrated that obesity (BMI ≥30kg/m2) is over twice as common amongst patients with CHC (28.8%) compared with the general Canadian population. Obesity superimposed on CHC reduces the success of antiviral treatment and promotes liver scarring (hepatic fibrosis), fatty liver (steatosis) and increases the risk of liver cancer. Both CHC and obesity contribute to IR putting these patients at risk of type 2 diabetes. IR, like obesity in CHC, reduces antiviral success rates. We have shown that diabetics are at higher risk of developing liver cancer compared with non-diabetics. It is therefore timely to address lifestyle modification to delay the onset of diabetes. We will examine the impact of a multidisciplinary lifestyle program on the insulin resistance in 52 obese "pre-diabetic" patients with current or past CHC. The 24 week program comprises an individualized nutritional and exercise plan supported by behavior modification counseling. Through gaining a better understanding of links between obesity, insulin resistance and hepatitis C infection we hope to delay the onset of diabetes and reduce the likelihood of all their untoward effects on the liver.


Condition Intervention
Obesity
Insulin Resistance
Metabolic Syndrome
Hepatitis C
Other: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of a Combined Program of Diet, Exercise and Behavior Modification on the Insulin Resistance and Adipokine Profile in Obese Patients With Current and Cured Chronic Hepatitis C.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • HOMA-IR [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TNF-alpha [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • leptin [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • fatigue score [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • mood score [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • cholesterol [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • triglycerides [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • RBC fatty acid composition [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Metabolic Syndrome [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • CLDQ (Chronic Liver Disease Questionnaire) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Liver and Peripheral Insulin Resistance [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Scores derived from glucose and insulin levels in the oral glucose tolerance test (OGTT)


Enrollment: 24
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 - Viremic / Non-cirrhotic
13 obese and insulin resistant, non-cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with chronic hepatitis C (HCV RNA positive) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who are naive to antiviral therapy, relapsed or not responded to antiviral therapy.
Other: Lifestyle intervention

The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):

i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits.

ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater).

iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided.

Active Comparator: Group 2 - Non-viremic / Non-cirrhotic
13 obese and insulin resistant, non-cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with cured chronic hepatitis C (HCV RNA negative) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who have cleared hepatitis C virus with previous antiviral therapy.
Other: Lifestyle intervention

The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):

i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits.

ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater).

iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided.

Experimental: Group 3 - Viremic / Cirrhotic
13 obese and insulin resistant, cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with chronic hepatitis C (HCV RNA positive) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who are naive to antiviral therapy, relapsed or not responded to antiviral therapy.
Other: Lifestyle intervention

The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):

i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits.

ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater).

iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided.

Active Comparator: Group 4 - Non-viremic / Cirrhotic
13 obese and insulin resistant, cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with cured chronic hepatitis C (HCV RNA negative) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who have cleared hepatitis C virus with previous antiviral therapy
Other: Lifestyle intervention

The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):

i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits.

ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater).

iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obese (BMI >/= 30)
  • insulin resistant (HOMA-IR >/= 2.1)

Exclusion Criteria:

  • Genotype 3 patients
  • Women with ongoing pregnancy or who are breast-feeding
  • Patients with any other other underlying liver disease (viral, alcoholic, druginduced, autoimmune, metabolic, genetic).
  • Patients currently on antiviral therapy, or who have ceased therapy within 6 months of recruitment to the study.
  • Patients with other causes for insulin resistance e.g., excess counter-regulatory hormones: glucocorticoids, catecholamines, growth hormone, polycystic ovary syndrome).
  • Patients on steroids or other drug that affects insulin resistance, which are unable to be stopped for 3 days prior to IR testing.
  • Patients with overt diabetes (based on results of fasting plasma glucose) will be excluded from participation as we are focusing on insulin resistance in the absence of diabetes.
  • Conditions which preclude a sudden increase in physical activity:

    • History or other evidence of chronic pulmonary disease associated with functional limitation.
    • History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
    • Unable to 10000 steps/day eg physical disability, morbid obesity.
  • Evidence of ongoing substance use (including alcohol consumption >20g/day for men and >10g/day for women) within one year of study recruitment.
  • Poor veins (inadequate venous access)
  • Inability or unwillingness to provide informed consent or abide by study requirements eg severe psychiatric illness, lives remotely, time commitment.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00755742

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Elizabeth J Heathcote, MD FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Venessa Pattullo, Research Collaborator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00755742     History of Changes
Other Study ID Numbers: 08-0545-AE
Study First Received: September 17, 2008
Last Updated: September 21, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
obesity
insulin resistance
metabolic syndrome
hepatitis C
adipokine
TNF
leptin
adiponectin
fatigue
mood
depression
exercise
diet
counseling
behavior modification

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Obesity
Hepatitis C
Syndrome
Hepatitis, Chronic
Hepatitis C, Chronic
Metabolic Syndrome X
Insulin Resistance
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Flaviviridae Infections
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 18, 2014